Conectar
by Naruyoshi Gyoutoku, Yukihiro Inoguchi, Junjiro Rikitake, Mutsuyuki Demiya, Mizuki Gobaru, Ayako Nagayama, Shimpei Iwata, Nao Hasuzawa, Hitomi Nakayama, Kenji Ashida, Masatoshi Nomura
ObjectivePreclinical studies, including animal and in vitro experiments, have suggested that imeglimin, a novel antidiabetic drug, may have beneficial effects on metabolic dysfunction-associated steatotic liver disease (MASLD). However, its effect on MASLD in individuals with type 2 diabetes remains unclear. This study aimed to evaluate whether imeglimin has beneficial effects in individuals with type 2 diabetes and hepatic enzyme abnormalities.
MethodsThis multicenter, retrospective, single-arm study included 49 individuals with type 2 diabetes who newly initiated imeglimin treatment and continued it for six months. Individuals with chronic liver diseases other than MASLD were excluded. Treatment efficacy for liver function was defined as an ALT reduction of ≥11 IU/L, corresponding to the upper interquartile range of ALT reduction. Logistic regression analysis was performed to identify predictors of this treatment efficacy.
ResultsBody mass index (BMI) and hemoglobin A1c (HbA1c) levels significantly decreased after six months of imeglimin treatment. Additionally, both alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels significantly decreased (ALT: 21.0 IU/L [13.0–39.0] vs. 17.0 [12.5–28.0], p = 0.002; AST: 21.0 IU/L [17.0–30.0] vs. 18.0 [16.0–26.0], p = 0.010, respectively). Logistic regression analysis showed that baseline ALT and AST levels were significant predictors of treatment efficacy for liver function, after adjusting for HbA1c and BMI levels (OR 1.06, 95% CI 1.02–1.12, p = 0.006; OR 1.12, 95% CI 1.06–1.23, p = 0.002, respectively). Furthermore, the receiver operating characteristic (ROC) curve for baseline ALT as a predictor demonstrated excellent discriminatory performance (Area under the curve: 0.905, p = 0.004). A cutoff value of 25 IU/L yielded 100% sensitivity and 77.8% specificity.
ConclusionThis exploratory study suggests that imeglimin may have beneficial effects in individuals with type 2 diabetes and elevated ALT (≥25 IU/L), potentially associated with MASLD. Randomized controlled trials are needed to confirm these findings.
The intestinal microbiota of people with Parkinson’s disease (PwP) differs significantly from that of healthy individuals. Given that altered microbiota may play a role in the pathogenesis of Parkinson’s disease, faecal microbiota transplantation (FMT) has been proposed as a potential therapeutic approach. However, the efficacy of FMT in improving motor symptoms in PwP has been inconclusive in some pilot randomised controlled trials (RCT). Previous RCTs on PwP employed simple FMT, but our modified approach—pretreatment with antibiotics before FMT (A-FMT)—has been shown to improve the engraftment rate of given species and the beneficial effects of FMT. This study aims to evaluate the efficacy and safety of A-FMT for PwP, particularly in those with motor fluctuations.
This study is a randomised, double-blind, placebo-controlled, parallel-group study with an 8-week observation period following a single A-FMT. Thirty clinically established PwP with prominent motor fluctuation episodes will be randomised 1:1 to FMT or placebo. Participants in both groups will receive antibiotic treatment prior to colonoscopy for FMT or placebo treatment. Primary and secondary endpoints will include subjective and objective evaluations of motor and non-motor symptoms and will be evaluated before and after antibiotic treatment and at 4 and 8 weeks after the procedure. Exploratory endpoints will include blood and faecal sample analyses, advanced brain MRI and pharmacokinetic assessment of levodopa concentrations during a levodopa challenge test.
This study has been approved by the ethical committee of Juntendo University in August 2024 (J24-005) and will be conducted in accordance with the Declaration of Helsinki, the Japan Ministry of Health, Labour and Welfare Clinical Trials Act and related laws and regulations. All patient data will be anonymised to protect privacy and used solely for study purposes. Results will be published in academic journals and presented at conferences.
jRCTs031240344.
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