Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes: A Pilot Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This pilot 12-week randomized open-label study compares metformin and berberine in newly diagnosed type 2 diabetes patients stratified by the TCF7L2 (rs7903146) genotype (TT vs. CC). The primary goal is to assess changes in HbA1c between metformin and berberine treated groups within each genotype. Secondary outcomes include fasting and postprandial glucose, insulin levels, HOMA-IR, body weight/BMI, lipid profile and adverse events.
The central hypothesis is that berberine, through its additional effect on TCF7L2-linked pathways, will provide superior glycemic control in high-risk TT carriers compared to metformin, whereas both treatments will yield comparable results in CC carriers. By enrolling only TT and CC genotypes, this study aims to estimate effect sizes and feasibility, guiding a future, larger-scale trial on genotype-tailored diabetes therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 30-65 years;
- •Newly diagnosed T2DM ≤1 year;
- •Baseline HbA1c: 7.0-9.0% (53-75 mmol/mol);
- •No prior use of antihyperglycemic agents or ≤4 weeks of usage;
- •Willing to sign informed consent and undergo TCF7L2 genotyping;
- •TT or CC genotype (rs7903146)
排除标准
- •Severe comorbidities (hepatic, renal, cardiac dysfunction);
- •Pregnancy or lactation;
- •Known allergy or intolerance to metformin or berberine;
- •Participation in another clinical trial within the last 3 months;
- •TC genotype (excluded).
研究组 & 干预措施
Metformin Group
Initial dose: 500 mg twice daily
- Titration: increased to 1,000 mg twice daily by Week 2 if tolerated
- Maximal dose: 2,000 mg/day
干预措施: Metformin (Drug)
Berberine Group
- Dose: 500 mg three times daily (1,500 mg/day total)
- Formulation: standardized berberine HCl tablets
- Duration: 12 weeks
干预措施: Berberine (Dietary Supplement)
结局指标
主要结局
Change in HbA1c
时间窗: 12 weeks
Change in HbA1c from baseline to Week 12 in each genotype group (TT or CC), comparing: TT + Berberine vs. TT + Metformin
Change in HbA1c from baseline (CC + Berberine vs. CC + Metformin)
时间窗: 12 weeks
次要结局
- LDL-C change(12 weeks)
- Fasting Plasma Glucose change (FPG)(12 weeks)
- HOMA-IR change(12 weeks)
- Total Cholesterol change(12 weeks)
- Postprandial Glucose (PPG) change(12 weeks)
- Serum Insulin Levels(12 weeks)
- Body Weight in kg change(12 weeks)
- Triglycerides change(12 weeks)
- HDL-C change(12 weeks)
- Number of any adverce events(12 weeks)