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☐ ☆ ✇ BMJ Open

How do people living with obesity who use obesity services perceive healthcare professionals representation of the disease on social media? An interpretative phenomenological analysis

Por: Maher · S. · McHugh · J. · Crotty · M. · Birney · S. · OConnell · J. · Finucane · F. · Spooner · M. — Abril 16th 2024 at 08:27
Objectives

The objective of this study was to explore how people living with obesity who use obesity services perceive healthcare professionals’ (HCPs) online representation of the disease on social media. By exploring their perspective, we aimed to develop a framework to inform good practice around social media use for HCPs.

Design

This was a qualitative study using a phenomenological framework. Following in-depth semi-structured interviews, analysis was undertaken to identify superordinate themes relating to how HCPs portray living with obesity online.

Setting

Patient advocacy organisation (The Irish Coalition for People Living with Obesity) and three clinical sites offering obesity treatment in Ireland.

Participants

15 adult participants comprising of 12 women and 3 men who use social media and are living with obesity and who use obesity services.

Results

Three key themes of how people living with obesity who use obesity services perceive HCP’s online representation of the disease. (1) Negative experiences of HCPs—participants describe encountering weight stigma and bias on social media from HCPs that they characterised as simplistic and outdated conceptualisations. These engender shame, fear and anger. (2) Positive experience of HCPs—participants report social media allows HCPs to educate and inform public perception of obesity. Positive online experiences lead to feelings of inclusion, understanding and encouragement. (3) Expectations of HCPs—qualifications, professional titles and academic association affected the perceived trustworthiness of information and its impact on readers. Participants feel there is a duty of care for HCPs in obesity medicine to advocate and be active online to provide accurate medical information.

Conclusion

HCP’s use of social media has a powerful impact on people with obesity who use healthcare and obesity services. Social media is a key tool in obesity awareness and education. We propose the ‘3E’ framework—Empower, Evidence-Based and Educate and be educated to guide HCPs’ social media use.

☐ ☆ ✇ BMJ Open

Cardiovascular safety of evogliptin dual and triple therapy in patients with type 2 diabetes: a nationwide cohort study

Por: Park · S. · Jeong · H. E. · Oh · I.-S. · Hong · S. · Yu · S. H. · Lee · C. B. · Shin · J.-Y. — Abril 16th 2024 at 08:27
Objective

To investigate the risk of cardiovascular events associated with commonly used dual and triple therapies of evogliptin, a recently introduced dipeptidyl peptidase-4 inhibitor (DPP4i), for managing type 2 diabetes in routine clinical practice.

Design

A retrospective cohort study.

Setting

Korean Health Insurance Review and Assessment database.

Participants

Patients who initiated metformin-based dual therapy and metformin+sulfonylurea-based triple therapy in South Korea from 2014 to 2018.

Interventions

Initiation of combination therapy with evogliptin.

Primary and secondary outcome measures

Hazards of cardiovascular events, a composite endpoint of myocardial infarction, heart failure and cerebrovascular events, and its individual components. Cox proportional hazards model with propensity score-based inverse probability of treatment weighting were used to estimate HRs and 95% CIs.

Results

From the dual and triple therapy cohorts, 5830 metformin+evogliptin users and 2198 metformin+sulfonylurea+evogliptin users were identified, respectively. Metformin+evogliptin users, as compared with metformin+non-DPP4i, had a 29% reduced risk of cardiovascular events (HR 0.71, 95% CI 0.62 to 0.82); HRs for individual outcomes were cerebrovascular events (0.71, 95% CI 0.53 to 0.95), heart failure (0.70, 95% CI 0.59 to 0.82), myocardial infarction (0.89, 95% CI 0.60 to 1.31). Metformin+sulfonylurea+evogliptin users, compared with metformin+sulfonylurea+non-DPP4i, had a 24% reduced risk of cardiovascular events (0.76, 95% CI 0.59 to 0.97); HRs for individual outcomes were myocardial infarction (0.57, 95% CI 0.27 to 1.19), heart failure (0.74, 95% CI 0.55 to 1.01), cerebrovascular events (0.96, 95% CI 0.61 to 1.51).

Conclusions

These findings suggest that dual or triple therapies of evogliptin for the management of type 2 diabetes in routine clinical practice present no cardiovascular harms, but could alternatively offer cardiovascular benefits in this patient population.

☐ ☆ ✇ BMJ Open

Do patients with type 2 diabetes mellitus included in randomised clinical trials differ from general-practice patients? A cross-sectional comparative study

Por: Dugard · A. · Giraudeau · B. · Dibao-Dina · C. — Abril 11th 2024 at 17:57
Objectives

To compare the characteristics of patients with type 2 diabetes mellitus in general practice and those included in randomised controlled trials on which clinical practice guidelines are based.

Design

Cross-sectional comparative study.

Setting

We asked 45 general practitioners from three French Departments to identify the 15 patients with type 2 diabetes mellitus they most recently saw in consultation. In parallel, we selected randomised controlled trials included in the Cochrane systematic review on which the clinical practice guidelines for type 2 diabetes mellitus were based.

Participants

We included 675 patients with type 2 diabetes mellitus, and data were collected from 23 randomised controlled trials, corresponding to 36 059 patients.

Outcome measures

Characteristics of general-practice patients were extracted from medical records by a unique observer. The same baseline characteristics of patients included in randomised controlled trials from the Cochrane systematic review were extracted and meta-analysed. We assessed standardised differences between these two series of baseline characteristics. A difference greater than 0.10 in absolute value was considered meaningful.

Results

General-practice patients were older than randomised controlled trial patients (mean (SD) 68.8 (1.1) vs 59.9 years (standardised difference 0.8)) and had a higher body mass index (mean (SD) 31.5 (6.9) vs 28.2 kg/m2 (standardised difference 0.5)) but smoked less (11.0% vs 29.3% (standardised difference –0.6)). They more frequently used antihypertensive drugs (82.1% vs 37.5% (standardised difference 1.2)) but less frequently had a myocardial infarction (7.6% vs 23.1% (standardised difference –1.1)).

Conclusions

Patients with type 2 diabetes mellitus cared for in general practice differ in a number of important aspects from patients included in randomised controlled trials on which clinical practice guidelines are based. This situation hampers the applicability of these guidelines. Future randomised trials should include patients who better fit the ‘average’ general-practice patient with type 2 diabetes mellitus to help improve the translation of study findings in daily practice.

☐ ☆ ✇ BMJ Open

Incidence of hypopituitarism in adults undergoing radiotherapy for neck and head cancer: protocol for a systematic review and meta-analysis

Por: Barros-Sevillano · S. · Cabanillas-Lazo · M. · Sedano-Chiroque · F. L. · Escajadillo-Vergara · C. · Espinoza-Martinez · D. · Pinedo-Torres · I. — Abril 3rd 2024 at 18:19
Introduction

When children with head and neck cancer receive radiation therapy as part of their treatment, a considerable frequency of hypopituitarism has been recognised. However, in adults, it has been little studied and it is possible that patients may be inadvertently affected. The objective is to estimate the incidence of anterior pituitary dysfunction in adults undergoing radiotherapy for head and neck cancer.

Methods and analysis

A total of five databases will be used to perform the document search: PubMed, Scopus, Web of Science (Core Collection), Ovid-MEDLINE and Embase. Cohort studies will be included without restriction by language or date. The main outcome will be the incidence of adenohypophyseal dysfunction for each axis: prolactin, growth hormone, thyroid-stimulating hormone, adrenocorticotropic hormone, luteinising hormone and follicle-stimulating hormone. Incidence meta-analysis will be performed using the Freeman-Tukey double arcsine method. In addition, a random-effects model will be used along with a 95% CI. Subgroup analyses will be performed according to tumour location, radiation dose and endocrine assessment time. Meta-regression will be applied according to patient’s age and time elapsed until diagnosis.

Ethics and disclosure

Since this will be a systematic review of published data, no ethics committee approval is required. The results will be presented at conferences and finally published in a peer-reviewed journal.

PROSPERO registration number

CRD42021235163.

☐ ☆ ✇ BMJ Open

Portuguese observational cross-sectional clinical imaging study protocol to investigate central dopaminergic mechanisms of successful weight loss through bariatric surgery

Por: Pais · M. L. · Crisostomo · J. · Abrunhosa · A. · Castelo-Branco · M. — Abril 3rd 2024 at 04:16
Introduction

Bariatric surgery (BS) is the treatment of choice for refractory obesity. Although weight loss (WL) reduces the prevalence of obesity-related comorbidities, not all patients maintain it. It has been suggested that central mechanisms involving dopamine receptors may play a role in successful WL. This protocol describes an observational cross-sectional study to test if the binding of central dopamine receptors is similar in individuals who responded successfully to BS and age- and gender-matched normal-weight healthy individuals (controls). As secondary goals, the protocol will investigate if this binding correlates with key parameters such as age, hormonal status, anthropometric metrics and neurobehavioural scores. Finally, as exploratory goals, we will include a cohort of individuals with obesity before and after BS to explore whether obesity and type of BS (sleeve gastrectomy and Roux-en-Y gastric bypass) yield distinct binding values and track central dopaminergic changes resulting from BS.

Methods and analysis

To address the major research question of this observational study, positron emission tomography (PET) with [11C]raclopride will be used to map brain dopamine type 2 and 3 receptors (D2/3R) non-displaceable binding potential (BPND) of individuals who have successfully responded to BS. Mean regional D2/3R BPND values will be compared with control individuals by two one-sided test approaches. The sample size (23 per group) was estimated to demonstrate the equivalence between two independent group means. In addition, these binding values will be correlated with key parameters to address secondary goals. Finally, for exploratory analysis, these values will be compared within the same individuals (before and after BS) and between individuals with obesity and controls and types of BS.

Ethics and dissemination

The project and informed consent received ethical approval from the Faculty of Medicine and the Coimbra University Hospital ethics committees. Results will be disseminated in international peer-reviewed journals and conferences.

☐ ☆ ✇ BMJ Open

Information needs on type 1 diabetes mellitus (T1DM) and its management in children and adolescents: a qualitative study

Por: Muhammed Elamin · S. · Muhamad Arshad · N. F. · Md Redzuan · A. · Abdul Aziz · S. A. · Hong · J. · Chua · X. Y. · Bin-Abbas · B. S. · Alsagheir · A. · Mohamed Shah · N. — Abril 3rd 2024 at 04:16
Objective

The objective of this study is to explore the information needs related to insulin therapy in children and adolescents with type 1 diabetes mellitus (T1DM) from the children’s perspectives as well as their caregivers.

Design

Qualitative study; semistructured interviews. To identify emerging themes relating to information needs, open coding and thematic analysis were employed.

Setting

Participants were recruited from a tertiary care children’s hospital in Kuala Lumpur, Malaysia and a specialist hospital in Riyadh, Saudi Arabia.

Participants

Thirty one children with a mean age of 11.5 years (SD=1.9) and their caregivers were interviewed. Seventeen participants were from Malaysia and 14 were from Saudi Arabia.

Results

Four themes of information emerged from the interviews, including information related to (1) hypoglycaemia and hyperglycaemia, (2) insulin therapy, (3) injection technique and (4) other information needs pertaining to continuous glucose monitoring, access to peer groups and future advances in insulin therapy.

Conclusion

This study provided valuable insights into the information needs related to T1DM and insulin therapy among children and adolescents with T1DM that should be considered by stakeholders in the development of age-appropriate education materials. Such materials will assist children and adolescents to better manage their life-long T1DM condition from adolescence until adulthood.

☐ ☆ ✇ BMJ Open

Relationship between social isolation and glycaemic control of people previously diagnosed with diabetes: secondary analysis from the CHARLS

Por: Lu · Q. · Qu · L. · Xie · C. · Shu · Y. · Gao · F. · Zou · M. · Fan · X. · Luo · X. · Meng · J. · Xue · Y. · Cao · Y. — Marzo 20th 2024 at 05:26
Objectives

Social isolation may affect diabetes self-management. This study aimed to explore the relations between social isolation and glycaemic control in patients with diabetes and to explore lifestyle differences among individuals with different levels of social isolation.

Methods

The relevant data of 665 people previously diagnosed with diabetes included in the China Health and Retirement Longitudinal Study from 2011 to 2015 were extracted and analysed. The study included patient general information, blood glucose, lipids, glycosylated haemoglobin, social isolation index, health-related lifestyle factors and diabetes-related factors. Differences in metabolic abnormalities and modifiable lifestyles were compared among patients with varying levels of social isolation.

Results

Multiple linear regression analysis demonstrated that among men aged 45–64 years, the high social isolation group had significantly higher glycosylated haemoglobin levels compared with the low isolation group (7.29±1.81 vs 6.59±1.63, p=0.026). A positive correlation was observed between social isolation and blood glucose (β=14.16; 95% CI 2.75 to 25.57; p=0.015) and glycosylated haemoglobin (β=0.35; 95% CI 0.10 to 0.60; p=0.006), indicating that higher social isolation was associated with higher fasting blood glucose and glycosylated haemoglobin levels. However, no significant associations were observed in other age groups. Notably, men aged 45–65 years with high social isolation had higher depression rates (44.10% vs 24.60%, p=0.024), lower engagement in moderate exercise (5.70% vs 23.50%, p=0.019) and shorter 10-minute walks (17.10% vs 36.80%, p=0.027). Differences in other health-related and diabetes-related factors were not statistically significant.

Conclusion

Middle-aged men with diabetes with higher social isolation tend to have higher blood glucose and glycosylated haemoglobin levels. This subset of patients requires targeted attention to provide social support from family and friends for improved glycaemic control. If necessary, education on diabetes should be made available to family members and friends.

☐ ☆ ✇ BMJ Open

Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

Por: Bansal · S. · Canziani · M. E. F. · Birne · R. · Anker · S. D. · Bakris · G. L. · Filippatos · G. · Rossing · P. · Ruilope · L. M. · Farjat · A. E. · Kolkhof · P. · Lage · A. · Brinker · M. · Pitt · B. — Marzo 20th 2024 at 05:26
Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993, NCT02545049.

☐ ☆ ✇ BMJ Open

Association of thyroid autoantibodies and diabetic kidney disease in hospitalised patients with type 2 diabetes mellitus: a cross-sectional study from a Chinese university hospital

Por: Wang · Z. · Wang · F. · Liu · C. · Zhang · L. — Marzo 19th 2024 at 04:02
Objectives

To analyse and explore the association between thyroid autoantibodies and diabetic kidney disease (DKD) in patients with type 2 diabetes mellitus (T2DM).

Design

A cross-sectional study.

Setting

Patients were from the inpatient unit at The Second Endocrinology Department of Shengjing Hospital Affiliated to China Medical University (Shenyang, China) between January 2015 and September 2019.

Participants

A total of 150 Chinese adults with T2DM were included in the study, including 83 men and 67 women. Their age ranged between 25 and 92 years.

Methodology

They grouped by the presence of DKD, urine albumin-to-creatinine ratio (UACR), estimated glomerular filtration rate, and levels of thyroid peroxidase antibodies (TPOAb) and thyroglobulin antibodies (TgAb). Data on the patients’ general characteristics and laboratory measurements (levels of fasting plasma glucose, glycated haemoglobin, and albumin; renal function; and thyroid function) were collected. Binary logistic regression was performed to identify risk factors for DKD.

Results

The level of TPOAb, the positivity rates of TPOAb (p

Conclusions

TPOAb-positive status is in association with DKD in patients with T2DM. Large scale, prospective cohort studies are warranted to confirm our findings.

☐ ☆ ✇ BMJ Open

Epidemiology of diabetes mellitus in Pakistan: a systematic review protocol

Por: Hasan · S. U. · Siddiqui · M. A. R. — Marzo 13th 2024 at 05:20
Introduction

Diabetes mellitus (DM) is a chronic metabolic disorder characterised by hyperglycaemia resulting from defects in insulin secretion, insulin action or both. As a major global health concern, its prevalence has been steadily increasing. Pakistan, is no exception to this trend, facing a growing burden of non-communicable diseases including DM. This research aims to comprehensively assess the prevalence of DM, and disparities between rural and urban populations as well as between men and women in Pakistan.

Methods and analysis

The systematic review will follow Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and will aim to assess DM prevalence in Pakistan. A comprehensive search strategy will be applied to databases like PubMed, Scopus, Cochrane, PakMediNet and CINAHL from inception up to 1st April 2024. We will include studies that focus on diabetes prevalence in the general population, employing WHO or American Diabetes Association criteria for diagnosis of DM. Cross-sectional studies, cohort studies and population-based surveys with a sample size ≥500, in English will be considered. Data extraction will be done as per a predefined proforma which will include study details such as demographics, prevalence data and methodology. A meta-analysis will be performed using a random effect model with an inverse variance weighted method. I2 statistics will be used to examine heterogeneity, and subgroup analyses will be performed.

Ethics and dissemination

The findings from the systematic review will be shared by publishing them in a peer-reviewed journal and showcasing them at pertinent conferences. Our analysis will be based on aggregated data and will not involve individual patient information, thus eliminating the need for ethical clearance.

PROSPERO registration number

CRD42023453085.

☐ ☆ ✇ BMJ Open

Effect and safety of electroacupuncture on weight loss in obese patients with pre-diabetes: study protocol of a randomised controlled trial

Por: Li · X. · Lin · J. · Hu · C. · Liu · B. · Li · F. · Li · J. · Zeng · X. · Li · S. · Mi · Y. · Yin · X. · Xu · S. — Marzo 9th 2024 at 02:25
Introduction

Obesity has been identified as a significant risk factor for several chronic conditions, including diabetes, tumours and cardiovascular disease, and has been associated with increased mortality rates. Despite the well-established clinical practice of electroacupuncture (EA) as a potential treatment option for obesity, its efficacy remains questionable, primarily due to the paucity of empirical evidence supporting its therapeutic benefits.

Methods and analysis

The present study aims to investigate the efficacy and safety of EA for weight loss in obese individuals with pre-diabetes, using a randomised, placebo-controlled clinical trial design. A total of 256 eligible patients will be randomly assigned to one of two groups: EA (comprising EA treatment with health education) or superficial acupuncture (SA) (comprising SA treatment with health education). The intervention will be administered three times per week for the initial 12 weeks, two times per week for the subsequent 8 weeks and one time per week for the final 4 weeks, with a 24-week follow-up period. The primary outcome measure will be the percentage of patients who achieve a reduction of 10% or more in their body weight at week 24. Secondary outcome measures will include changes in body weight and body mass index, blood test results, data collected by the body composition analyser, size of adipose tissue scanned by MRI of the abdomen and the Impact of Weight on Quality of Life, the 21-item Three-Factor Eating Questionnaire-Revised and the Food Craving Questionnaire-Trait. The Treatment Emergent Symptom Scale will be employed to monitor every adverse reaction from baseline to follow-up.

Ethics and dissemination

This trial has received ethical clearance from the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine under the registration number 2021SHL-KY-74. All participants will provide their written informed consent prior to their enrolment. The findings of this investigation will be disseminated through peer-reviewed publications and scholarly conferences.

Trial registration number

NCT05237089.

☐ ☆ ✇ BMJ Open

Diabetes care in the pandemic era in the Midwestern USA: a semi-structured interview study of the patient perspective

Por: Gonzalez Bravo · C. · Sabree · S. A. · Dukes · K. · Adeagbo · M. J. · Edwards · S. · Wainwright · K. · Schaeffer · S. E. · Villa · A. · Wilks · A. D. · Carvour · M. L. — Marzo 9th 2024 at 02:25
Objectives

To understand patients’ experiences with diabetes care during the COVID-19 pandemic, with an emphasis on rural, medically underserved, and/or minoritised racial and ethnic groups in the Midwestern USA.

Design

Community-engaged, semi-structured interviews were conducted by medical student researchers trained in qualitative interviewing. Transcripts were prepared and coded in the language in which the interview was conducted (English or Spanish). Thematic analysis was conducted, and data saturation was achieved.

Setting

The study was conducted in communities in Eastern and Western Iowa.

Participants

Adults with diabetes (n=20) who were fluent in conversational English or Spanish were interviewed. One-third of participants were residents of areas designated as federal primary healthcare professional shortage areas and/or medically underserved areas, and more than half were recruited from medical clinics that offer care at no cost.

Results

Themes across both English and Spanish transcripts included: (1) perspectives of diabetes, care providers and care management; (2) challenges and barriers affecting diabetes care; and (3) participant feedback and recommendations. Participants reported major constraints related to provider availability, costs of care, access to nutrition counselling and mental health concerns associated with diabetes care during the pandemic. Participants also reported a lack of shared decision-making regarding some aspects of care, including amputation. Finally, participants recognised systems-level challenges that affected both patients and providers and expressed a preference for proactive collaboration with healthcare teams.

Conclusions

These findings support enhanced engagement of rural, medically underserved and minoritised groups as stakeholders in diabetes care, diabetes research and diabetes provider education.

☐ ☆ ✇ BMJ Open

Codesigning enhanced models of care for Northern Australian Aboriginal and Torres Strait Islander youth with type 2 diabetes: study protocol

Por: Kirkham · R. · Puszka · S. · Titmuss · A. · Freeman · N. · Weaver · E. · Morris · J. · Mack · S. · O'Donnell · V. · Boffa · J. · Dowler · J. · Ellis · E. · Corpus · S. · Graham · S. · Scott · L. · Sinha · A. K. · Connors · C. · Shaw · J. E. · Azzopardi · P. · Brown · A. · Davis · E. · Wicklow — Marzo 7th 2024 at 10:14
Introduction

Premature onset of type 2 diabetes and excess mortality are critical issues internationally, particularly in Indigenous populations. There is an urgent need for developmentally appropriate and culturally safe models of care. We describe the methods for the codesign, implementation and evaluation of enhanced models of care with Aboriginal and Torres Strait Islander youth living with type 2 diabetes across Northern Australia.

Methods and analysis

Our mixed-methods approach is informed by the principles of codesign. Across eight sites in four regions, the project brings together the lived experience of Aboriginal and Torres Strait Islander young people (aged 10–25) with type 2 diabetes, their families and communities, and health professionals providing diabetes care through a structured yet flexible codesign process. Participants will help identify and collaborate in the development of a range of multifaceted improvements to current models of care. These may include addressing needs identified in our formative work such as the development of screening and management guidelines, referral pathways, peer support networks, diabetes information resources and training for health professionals in youth type 2 diabetes management. The codesign process will adopt a range of methods including qualitative interviews, focus group discussions, art-based methods and healthcare systems assessments. A developmental evaluation approach will be used to create and refine the components and principles of enhanced models of care. We anticipate that this codesign study will produce new theoretical insights and practice frameworks, resources and approaches for age-appropriate, culturally safe models of care.

Ethics and dissemination

The study design was developed in collaboration with Aboriginal and Torres Strait Islander and non-Indigenous researchers, health professionals and health service managers and has received ethical approval across all sites. A range of outputs will be produced to disseminate findings to participants, other stakeholders and the scholarly community using creative and traditional formats.

☐ ☆ ✇ BMJ Open

Knowledge, attitude and practices of insulin therapy among patients with type 2 diabetes: a cross-sectional study

Por: Almheiri · A. · Binjab · E. A. · Albloushi · M. M. · Alshamsi · M. T. · Khansaheb · H. H. · Zidan · M. · Hassoun · A. A. K. — Marzo 6th 2024 at 05:12
Objectives

This study aimed to assess the knowledge, attitude and practices of patients with type 2 diabetes on insulin regarding insulin therapy.

Design

A cross-sectional study.

Setting

This study was conducted at the Dubai Diabetes Center from 1 December 2018 to 1 March 2020.

Participants

Face-to-face interviews were conducted for 350 participants with type 2 diabetes at the Dubai Diabetes Center. Interviews followed the structured format of a questionnaire designed to obtain demographic details and score participants on knowledge, attitude and practices. We included patients aged >18 years and receiving insulin therapy. Patients with type 1 diabetes, pregnant women with gestational diabetes, those aged

Results

The median age of participants was 61 years (first quartile, 53 years; third quartile, 67 years); 35.7% were male individuals and 64.3% were female individuals. The median percentage scores for knowledge, attitude and practices were 62.5% (62.5%, 75%), 85.7% (71.4%, 100%) and 77.7% (66.6%, 88.8%), respectively. Highly educated participants had a high level of knowledge. Significant negative correlations were found between the percentage knowledge scores and participants’ age and between the participants’ percentage attitude scores and haemoglobin A1C levels; Spearman’s correlations were –0.182 (p

Conclusion

Patients with type 2 diabetes receiving insulin therapy and attending the Dubai Diabetes Center had adequate knowledge, a positive attitude and correct practice regarding insulin therapy. However, knowledge of specific facts did not always translate into correct behaviours and practices.

☐ ☆ ✇ BMJ Open

Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol

Por: Merolla · A. · De Lorenzo · R. · Ferrannini · G. · Renzi · C. · Ulivi · F. · Bazzigaluppi · E. · Lampasona · V. · Bosi · E. — Marzo 6th 2024 at 05:12
Introduction

Chronic autoimmune (type 1 diabetes and coeliac disease) and metabolic/cardiovascular (type 2 diabetes, dyslipidaemia, hypertension) diseases are highly prevalent across all age ranges representing a major public health burden. Universal screening for prediction/early identification of these conditions is a potential tool for reducing their impact on the general population. The aim of this study is to assess whether universal screening using capillary blood sampling is feasible at a population-based level.

Methods and analysis

This is a low-risk interventional, single-centre, pilot study for a population-based screening programme denominated UNISCREEN. Participants are volunteers aged 1–100 who reside in the town of Cantalupo (Milan, Italy) undergoing: (1) interview collecting demographics, anthropometrics and medical history; (2) capillary blood collection for measurement of type 1 diabetes and coeliac disease-specific autoantibodies and immediate measurement of glucose, glycated haemoglobin and lipid panel by point-of-care devices; (3) venous blood sampling to confirm autoantibody-positivity; (4) blood pressure measurement; (5) fulfilment of a feasibility and acceptability questionnaire. The outcomes are the assessment of feasibility and acceptability of capillary blood screening, the prevalence of presymptomatic type 1 diabetes and undiagnosed coeliac disease, distribution of glucose categories, lipid panel and estimate of cardiovascular risk in the study population. With approximately 3000 inhabitants, the screened population is expected to encompass at least half of its size, approaching nearly 1500 individuals.

Ethics and dissemination

This protocol and the informed consent forms have been reviewed and approved by the San Raffaele Hospital Ethics Committee (approval number: 131/INT/2022). Written informed consent is obtained from all study participants or their parents if aged

Conclusions

If proven feasible and acceptable, this universal screening model would pave the way for larger-scale programmes, providing an opportunity for the implementation of innovative public health programmes in the general population.

Trial registration number

NCT05841719.

☐ ☆ ✇ BMJ Open

Prolonged Remission Induced by FENofibrate in children with newly diagnosed type 1 diabetes (PRIFEN): protocol of a randomised controlled trial

Por: Groele · L. · Dzygało · K. · Kowalska · A. · Szypowska · A. — Febrero 10th 2024 at 11:42
Introduction

Sphingolipids regulate proinsulin folding, insulin secretion and control beta cells apoptosis. Recent evidence has demonstrated that, among other factors, reduced amounts of sulfatide may be relevant in the development of type 1 diabetes (T1D). Thus, fenofibrate, which activates sulfatide biosynthesis, may prolong remission in subjects with T1D. The aim of the study is to evaluate clinical efficacy of fenofibrate on the maintenance of residual beta-cell function in children with newly diagnosed T1D.

Methods and analysis

A total of 102 children aged 10–17 years with newly diagnosed T1D will be enrolled in a double-blind, two-centre randomised, non-commercial, placebo-controlled trial. Subjects who will meet all inclusion criteria will be randomly assigned to receive fenofibrate at a dose of 160 mg or an identically appearing placebo, orally, once daily, for 12 months. The primary endpoint will be the area under the curve of the C-peptide level during 2-hour responses to a mixed-meal tolerance test (MMTT). Secondary endpoints include fasting and maximum C-peptide concentration in the MMTT, parameters of diabetes control and glucose fluctuations, daily insulin requirement, inflammation markers, genetic analysis, safety and tolerance of the fenofibrate

Ethics and dissemination

The study protocol was approved by the Bioethics Committee. The results of this study will be submitted to a peer-reviewed diabetic journal. Abstracts will be submitted to international and national conferences.

Trial registration number

EnduraCT 2020-003916-28.

☐ ☆ ✇ BMJ Open

Manchester Intermittent Diet in Gestational Diabetes Acceptability Study (MIDDAS-GDM): a two-arm randomised feasibility protocol trial of an intermittent low-energy diet (ILED) in women with gestational diabetes and obesity in Greater Manchester

Por: Dapre · E. · Issa · B. G. · Harvie · M. · Su · T.-L. · McMillan · B. · Pilkington · A. · Hanna · F. · Vyas · A. · Mackie · S. · Yates · J. · Evans · B. · Mubita · W. · Lombardelli · C. — Febrero 10th 2024 at 11:42
Introduction

The prevalence of gestational diabetes mellitus (GDM) is rising in the UK and is associated with maternal and neonatal complications. National Institute for Health and Care Excellence guidance advises first-line management with healthy eating and physical activity which is only moderately effective for achieving glycaemic targets. Approximately 30% of women require medication with metformin and/or insulin. There is currently no strong evidence base for any particular dietary regimen to improve outcomes in GDM. Intermittent low-energy diets (ILEDs) are associated with improved glycaemic control and reduced insulin resistance in type 2 diabetes and could be a viable option in the management of GDM. This study aims to test the safety, feasibility and acceptability of an ILED intervention among women with GDM compared with best National Health Service (NHS) care.

Method and analysis

We aim to recruit 48 women with GDM diagnosed between 24 and 30 weeks gestation from antenatal clinics at Wythenshawe and St Mary’s hospitals, Manchester Foundation Trust, over 13 months starting in November 2022. Participants will be randomised (1:1) to ILED (2 low-energy diet days/week of 1000 kcal and 5 days/week of the best NHS care healthy diet and physical activity advice) or best NHS care 7 days/week until delivery of their baby. Primary outcomes include uptake and retention of participants to the trial and adherence to both dietary interventions. Safety outcomes will include birth weight, gestational age at delivery, neonatal hypoglycaemic episodes requiring intervention, neonatal hyperbilirubinaemia, admission to special care baby unit or neonatal intensive care unit, stillbirths, the percentage of women with hypoglycaemic episodes requiring third-party assistance, and significant maternal ketonaemia (defined as ≥1.0 mmol/L). Secondary outcomes will assess the fidelity of delivery of the interventions, and qualitative analysis of participant and healthcare professionals’ experiences of the diet. Exploratory outcomes include the number of women requiring metformin and/or insulin.

Ethics and dissemination

Ethical approval has been granted by the Cambridge East Research Ethics Committee (22/EE/0119). Findings will be disseminated via publication in peer-reviewed journals, conference presentations and shared with diabetes charitable bodies and organisations in the UK, such as Diabetes UK and the Association of British Clinical Diabetologists.

Trial registration number

NCT05344066.

☐ ☆ ✇ BMJ Open

Burden of diabetic ketoacidosis among patients with diabetes mellitus in Ethiopia: a systematic review and meta-analysis

Por: Abera · E. G. · Yesho · D. H. · Erega · F. T. · Adulo · Z. A. · Gebreselasse · M. Z. · Gebremichael · E. H. — Febrero 10th 2024 at 11:42
Objectives

This systematic review and meta-analysis aimed to assess the magnitude and determinants of diabetic ketoacidosis (DKA) among patients with diabetes mellitus (DM) in Ethiopia.

Design

Systematic review and meta-analysis.

Participants

Age 15 and above all patients with diabetes with the diagnosis of DKA in Ethiopia

Data source

PubMed/MEDLINE, Cochrane Library, Science Direct, HINARI, Google Scholar and grey literatures were accessed to find relevant articles. Studies that have been conducted and reported in English language, articles with an available full-text, and observational studies were included. The task of searching sources was carried out from all stated electronic databases performed during 15 April–29 April 2023.

Primary and secondary outcome measures

Eligible studies were critically appraised by three independent reviewers for methodological quality in the review using standardised critical appraisal instruments from Joanna Briggs Institute (JBI) for observational studies. After the finally extracted studies were exported, systematic review and meta-analysis were conducted using Unified Management, Assessment and Review of Information (JBI SUMARI) (JBI, Adelaide, Australia) and STATA V.17 software. Sensitivity tests were done, and funnel plot inspections with Egger’s test were used to check for publication bias.

Result

From a total of 19 studies with 6498 study participants, the pooled prevalence of DKA among patients with DM in Ethiopia was 30.92% (95% CI 29.96 to 31.89) with a significant statistical heterogeneity (I2=99.2, p=

Conclusion

This systematic review and meta-analysis revealed that the prevalence of DKA among patients with DM in Ethiopia was 30.92%. Besides, different behavioural and clinical determinants of DKA among patients with DM were identified. However, further studies should be conducted, particularly on the possible determinants of DKA, and different stakeholders should be engaged to minimise its burden.

☐ ☆ ✇ BMJ Open

Study protocol for a prediction model for mild cognitive impairment in older adults with diabetes mellitus and construction of a nurse-led screening system: a prospective observational study

Por: Miao · W. · Lu · Y. · Xv · H. · Zheng · C. · Yang · W. · Qian · X. · Chen · J. · Geng · G. — Febrero 8th 2024 at 03:36
Introduction

With an increasing number of older adults in China, the number of people with cognitive impairment is also increasing. To decrease the risk of dementia, it is necessary to timely detect mild cognitive impairment (MCI), which is the preliminary stage of dementia. The prevalence of MCI is relatively high among older adults with diabetes mellitus (DM); however, no effective screening strategy has been designed for this population. This study will construct a nurse-led screening system to detect MCI in community-dwelling older adults with DM in a timely manner.

Methods and analysis

A total of 642 participants with DM will be recruited (n=449 for development, n=193 for validation). The participants will be divided into MCI and none-MCI groups. The candidate predictors will include demographic variables, lifestyle factors, history of diseases, physical examinations, laboratory tests and neuropsychological tests. Univariate analysis, least absolute shrinkage and selection operator regression screening, and multivariate logistic regression analysis will be conducted to identify the outcome indicators. Based on the multivariate logistic regression equation, we will develop a traditional model as a comparison criterion for the machine learning models. The Hosmer-Lemeshow goodness-of-fit test and calibration curve will be used to evaluate the calibration. Sensitivity, specificity, area under the curves and clinical decision curve analysis will be performed for all models. We will report the sensitivity, specificity, area under the curve and decision curve analysis of the validation dataset. A prediction model with better performance will be adopted to form the nurse-led screening system.

Ethics and dissemination

This prospective study has received institutional approval of the Medical Ethics Committee of Qidong Hospital of TCM (QDSZYY-LL-20220621). Study results will be disseminated through conference presentations, Chinese Clinical Trial Registry and publication.

Trial registration number

ChiCTR2200062855.

☐ ☆ ✇ BMJ Open

Implementing a contextually appropriate foot-ankle exercise programme in primary care for the prevention of modifiable risk factors for ulcers in people with diabetes: protocol for a hybrid type 2 study

Por: Rodrigues · C. B. · Soares · P. N. C. · Schmitt · A. C. B. · Sacco · I. C. N. — Febrero 6th 2024 at 02:59
Introduction

Diabetes is a highly prevalent disease that negatively impacts people’s health and quality of life. It can result in diabetic peripheral neuropathy (DPN) and foot complications, which in turn lead to ulcers and amputations. The international guidelines on diabetic foot included specific foot-ankle exercises as preventive strategy capable of modifying the risk factors for ulcers. Our aim is to test the effectiveness and to implement a contextually appropriate preventive intervention—a foot-ankle exercises programme alongside educational strategies—in a primary care setting to improve range of motion (ROM), strength, functionality of foot-ankle, and quality of life in people with diabetes.

Methods and analysis

This is a hybrid type 2 implementation-effectiveness study organised in four phases, being undertaken in Limeira, São Paulo. Phase 1, preimplementation, aims to gather information about the contextual characteristics, barriers, and facilitators and to form the implementation team. In phase 2, the implementation team will structure the foot-ankle programme, adapting it to the context of primary healthcare, and develop the training for health professionals. In phase 3, effectiveness of the 12 week group-based intervention will be tested by a cluster randomised controlled trial. Primary care units (18 clusters) will be randomly allocated to a control or intervention group, with a total sample of 356 people. Primary outcomes will be DPN symptoms and ankle and first metatarsal phalangeal joint ROM. Reach, adoption, and implementation will be evaluated by Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. In phase 4, maintenance and expansion of the programme in the municipality will be assessed.

Ethics and dissemination

This protocol and the informed consent to be signed by the participants were approved by the Ethics Committee of the School of Medicine of the University of São Paulo (CAAE:63457822.0.0000.0068, 29 November 2022). The project will generate and share data in a public repository. Results will be disseminated through peer-reviewed journals, conference proceedings, and electronic communications for health professionals.

Trial registration number

NCT05639478.

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