Enhancing the Efficacy and Tolerability of Metformin by add-on Polyherbal Formulation: a Gut Microbiome Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in Glycemic Control (HbA1c Levels)
研究概览
简要总结
Study population: Type 2 diabetes patients Design of the study: Randomized, two-arm, placebo-controlled, and prospective crossover cohort study.
Objective: To evaluate the effects of interactions between metformin and traditionally used polyherbal formulations on gut microbiota in a prospective crossover study involving type 2 diabetes mellitus patients.
Sample size: 66 patients. Duration of study: 06/2024 - 12/2026
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must meet all of the following criteria to be eligible for enrollment:
- •Clinical diagnosis of Type 2 Diabetes Mellitus (T2D) HbA1c level between 6.5% and 8.5% On a stable dose of oral antidiabetic therapy for at least 6 months Age: ≥ 25 years and ≤ 80 years History of metformin intolerance, defined as previously reported gastrointestinal side effects or inability to tolerate full-dose metformin Willing and able to provide written informed consent Willing to comply with study procedures, including stool sample collection and continuous glucose monitoring (CGM)
排除标准
- •Participants will be excluded if they meet any of the following criteria:
- •Type 1 Diabetes Mellitus Current or recent (last 6 months) use of polyherbal formulations (PHF) Pregnancy or breastfeeding
- •Severe diabetic complications, such as:
- •Diabetic ketoacidosis Proliferative retinopathy Chronic kidney disease Stage IIIb or higher (eGFR <45 mL/min/1.73m²)
- •Recent cardiovascular events (within the last 6 months), including:
- •Stroke Myocardial infarction Unstable angina Heart failure
- •Severe systemic disease that could interfere with participation, such as:
- •Active cancer Severe autoimmune disease Current antibiotic therapy (within 2 months of study enrollment) Use of probiotics or prebiotics (within 1 month of study enrollment)
- •Severe gastrointestinal conditions, including:
- •Inflammatory bowel disease Chronic diarrhea of unknown origin Severe infection requiring antibacterial therapy Participation in another interventional study within the last 3 months
研究组 & 干预措施
Polyherbal formulation
Participants in this arm will receive an add-on polyherbal formulation (PHF). Treatment Duration: 24 weeks, followed by a crossover to the placebo arm.
干预措施: Polyherbal Formulation (PHF) (Dietary Supplement)
Polyherbal formulation
Participants in this arm will receive an add-on polyherbal formulation (PHF). Treatment Duration: 24 weeks, followed by a crossover to the placebo arm.
干预措施: Metformin (Standard Treatment for Type 2 Diabetes) (Drug)
Placebo
Participants in this arm will receive a placebo. Treatment Duration: 24 weeks, followed by a crossover to the PHF arm.
干预措施: Placebo (Other)
Placebo
Participants in this arm will receive a placebo. Treatment Duration: 24 weeks, followed by a crossover to the PHF arm.
干预措施: Metformin (Standard Treatment for Type 2 Diabetes) (Drug)
结局指标
主要结局
Change in Glycemic Control (HbA1c Levels)
时间窗: Baseline, Week 24, Week 48
Measurement of HbA1c (%) to evaluate the impact of PHF on glycemic control compared to placebo.
次要结局
- Relative Abundance of Key Bacterial Taxa in Gut Microbiota(Baseline, Week 2, Week 24, Week 25, Week 48)
- Gastrointestinal Tolerability of Metformin(Baseline, Week 2, Week 24, Week 25, Week 48)
- Fasting and Postprandial Blood Glucose Levels(Baseline, Week 24, Week 48)
- Time in Range (TIR) Measured by Continuous Glucose Monitoring (CGM)(Week 1)
- Metabolomic Analysis of Stool Samples (Short-chain fatty acids (SCFAs))(Baseline, Week 24, Week 48)
- Patient-Reported Outcomes on Quality of Life(Baseline, Week 24, Week 48)
- Metabolomic Analysis of Stool Samples (Amino acids)(Baseline, Week 24, Week 48)
- Metabolomic Analysis of Stool Samples (Bile acids)(Baseline, Week 24, Week 48)
研究者
Valdis Pirags
Prof.
Pauls Stradins Clinical University Hospital