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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.
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.

Use of external control arms in immune-mediated inflammatory diseases: a systematic review

Por: Zayadi · A. · Edge · R. · Parker · C. E. · Macdonald · J. K. · Neustifter · B. · Chang · J. · Zhong · G. · Singh · S. · Feagan · B. G. · Ma · C. · Jairath · V.
Objectives

External control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to summarise applications of ECAs in trials of immune-mediated inflammatory diseases (IMIDs).

Design

Systematic review with an appraisal of ECA source quality rated across five domains (data collection, study populations, outcome definitions, reliability and comprehensiveness of the dataset, and other potential limitations) as high, low or unclear quality.

Data sources

Embase, Medline and Cochrane Central Register of Controlled Trial were searched through to 12 September 2023.

Eligibility criteria

Eligible studies were single-arm or randomised controlled trials (RCTs) of inflammatory bowel disease, pouchitis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis and atopic dermatitis in which an ECA was used as the comparator.

Data extraction and synthesis

Two authors independently screened the search results in duplicate. The characteristics of included studies, external data source(s), outcomes and statistical methods were recorded, and the quality of the ECA data source was assessed by two independent authors.

Results

Forty-three studies met the inclusion criteria (inflammatory bowel disease: 16, pouchitis: 1, rheumatoid arthritis: 12, juvenile idiopathic arthritis: 1, ankylosing spondylitis: 5, psoriasis: 3, multiple indications: 4). The majority of these trials were single-arm (33/43) and enrolled adult patients (34/43). All included studies used a historical control rather than a contemporaneous ECA. In RCTs, ECAs were most often derived from the placebo arm of another RCT (6/10). In single-arm trials, historical case series were the most common ECA source (19/33). Most studies (31/43) did not employ a statistical approach to generate the ECA from historical data.

Conclusions

Standardised ECA methodology and reporting conventions are lacking for IMIDs trials. The establishment of ECA reporting guidelines may enhance the rigour and transparency of future research.

Incidence of admission ionised hypocalcaemia in paediatric major trauma: protocol for a systematic review and meta-analysis

Por: Hibberd · O. · Price · J. · Harris · T. · Barnard · E. B. G.
Introduction

Hypocalcaemia forms part of the ‘diamond of death’ in major trauma, alongside hypothermia, acidosis and coagulopathy. In adults, admission hypocalcaemia prior to transfusion is associated with increased mortality, increased blood transfusion requirements and coagulopathy. Data on paediatric major trauma patients are limited. This systematic review and meta-analysis aims to describe and synthesise the available evidence relevant to paediatric trauma, admission hypocalcaemia and outcome.

Methods and analysis

The Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines will be used to construct this review. A planned literature search for articles in the English language will be conducted from inception to the date of searches using MEDLINE on the EBSCO platform, CINAHL on the EBSCO platform and Embase on the Ovid platform. The grey literature will also be searched. Both title and abstract screening and full-text screening will be done by two reviewers, with an adjudicating third reviewer. Heterogeneity will be assessed using the I2 test, and the risk of bias will be assessed using the ROBINS-I tool. A meta-analysis will be undertaken using ratio measures (OR) and mean differences for measures of effect. When possible, the estimate of effect will be presented along with a CI and a p value.

Ethical review and dissemination

Ethical review is not required, as no original data will be collected. Results will be disseminated through peer-reviewed publications and at academic conferences.

PROSPERO registration number

CRD42023425172.

Danish Prostate Cancer Consortium Study 1 (DPCC-1) protocol: Multicentre prospective validation of the urine-based three-microRNA biomarker model uCaP

Por: Fredsoe · J. · Glud · E. · Boesen · L. · Logager · V. · Poulsen · M. H. · Pedersen · B. G. · Borre · M. · Sorensen · K. D.
Introduction

The primary objective of the Danish Prostate Cancer Consortium Study 1 (DPCC-1) is to provide validation for a novel urine-based microRNA biomarker, called uCaP, for a diagnosis of prostate cancer.

Methods and analysis

Eligible participants are biopsy naïve men aged ≥18 years with prostate-specific antigen (PSA) levels ≥3 ng/mL, who are referred to prostate MRI due to suspicion of PC at one of the following three major urology/uroradiology centers: Aarhus University Hospital, Herlev & Gentofte University Hospital, or Odense University Hospital, where MRI and targeted biopsy are implemented in clinical use. Exclusion criteria include previous diagnosis of urogenital cancer, contraindication to MRI, gender reassignment treatment or PSA level >20 ng/mL. The participants will be asked to donate a urine sample in connection with their MRI. The study is observational, uses a diagnostic accuracy testing setup and will integrate into the current diagnostic pathway.

We will measure the levels of the three microRNAs in the uCaP model (miR-222–3 p, miR-24–3 p and miR-30c-5p) in extracellular vesicle-enriched cell-free urine samples, to assess if uCaP can improve specificity and retain sensitivity for International Society of Urological Pathology Grade Group ≥2 PC, when used as a reflex test to PSA ≥3 ng/mL. We hypothesise that uCaP can improve selection for prostate MRI and reduce the number of unnecessary scans and biopsies.

Ethics and dissemination

This study is approved by the Central Denmark Region Committee on Health Research Ethics (reference number: 1-10-72-85-22). All participants will provide written informed consent. Study results will be published in peer-reviewed journals and presented in scientific meetings.

Trial registration number

NCT05767307 at clinicaltrials.gov.

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