Comparison of effect of metformin plus Dapagliflozin Vs Metformin plus semaglutide on lean body mass and muscle strength in T2DM: A Randomized Controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- To compare the change in lean body mass and muscle strength assessed by DEXA Scan and hand grip dynamometer between metformin plus dapagliflozin group and metformin plus semaglutide group
研究概览
简要总结
Title of study is “Comparison of Effect of Metformin Plus Dapagliflozin Vs. Metformin Plus Semaglutide on Lean Body Mass And Muscle Strength In T2DM” It aims to compare the effects of two treatment regimens—metformin plus dapagliflozin versus metformin plus semaglutide—on lean body mass (LBM) and muscle strength in patients with type 2 diabetes mellitus (T2DM).
PICOT Population: Adults (40-60 years) diagnosed with T2DM Intervention: Metformin + dapagliflozin Comparison: Metformin + semaglutide
Outcome: Changes in lean body mass and muscle strength, and other biochemical parameters.
Timeframe: 3 months
Research Question: How do metformin combined with dapagliflozin versus metformin combined with semaglutide affect lean body mass and muscle strength in patients with T2DM over 3 months?
Aims and Objectives:
The primary aim is to compare lean body mass and muscle strength between the two treatment groups with DEXA scan.
Secondary objectives include comparing biochemical and physical parameters ((HbA1c, fasting and postprandial blood glucose levels, LFT, RFT, serum creatinine:cystatin C ratio, anthropometry, BMI, calf muscle measure) side effects, muscle strength using RMS of surface EMG and handgrip dynamometry, and muscle thickness using USG guided method between same 2 groups.
Inclusion and Exclusion Criteria Inclusion: Patients aged 40-60 with T2DM, HbA1C between 7% and 10%, on metformin. Exclusion: Patients with type 1 diabetes, chronic kidney disease, steroid use, pregnancy, malignancy, or other muscle-affecting disorders, previously on SGLT-2i or GLP-1 analogues, patients with diabetes for >15 years.
Expected Outcomes The study anticipates significant differences in LBM and muscle strength between the two groups. It is hypothesized that metformin with GLP-1 analogues may better preserve LBM and muscle strength compared to the metformin and SGLT-2 inhibitor combination, which may lead to LBM reduction. The results will guide more holistic treatment approaches for T2DM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed case of T2DM with HbA1C between 7% and 10%, and taking metformin but blood sugar uncontrolled and requires addition of another oral hypoglycemic agent (dapagliflozin or semaglutide).
排除标准
- •Pregnancy, type 1 diabetes mellitus, Malignancy patients on steroids or immune suppressants over long duration that is for more than 3 months, patients on exogenous insulin, patients previously on SGLT2 inhibitors or GLP1 analogues, patients having T2DM for more than 15 years, patients with chronic kidney disease that is with eGFR less than 30, patients with eating OR autoimmune OR thyroid OR muscle disorders, patients with Human Immunodeficiency Virus infection.
结局指标
主要结局
To compare the change in lean body mass and muscle strength assessed by DEXA Scan and hand grip dynamometer between metformin plus dapagliflozin group and metformin plus semaglutide group
时间窗: Baseline and at 3 months
次要结局
- To compare the change in HbA1c between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the change in fasting blood glucose between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the change in postprandial blood glucose between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the change in liver function tests between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the change in renal function tests between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the change in serum creatinine to cystatin C ratio between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the change in anthropometrical measurements between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline, at 1 month, 2 months and 3 months)
- To compare the change in BMI between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the change in calf muscle circumference between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the incidence of side effects between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
- To compare the change in lean body mass composition assessed by bioelectric impedance analysis between metformin plus dapagliflozin group and metformin plus semaglutide group(Baseline and at 3 months)
研究者
Dr Rimple Jeet Kaur
AIIMS Jodhpur