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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Metformin • 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
Berberine * Dose: 500 mg three times daily (1,500 mg/day total) * Formulation: standardized berberine HCl tablets * Duration: 12 weeks
Center for New Medical Technologies
Novosibirsk, Russia
Change in HbA1c
Change in HbA1c from baseline to Week 12 in each genotype group (TT or CC), comparing: TT + Berberine vs. TT + Metformin
Time frame: 12 weeks
Change in HbA1c from baseline (CC + Berberine vs. CC + Metformin)
Time frame: 12 weeks
Fasting Plasma Glucose change (FPG)
Time frame: 12 weeks
Postprandial Glucose (PPG) change
Time frame: 12 weeks
Serum Insulin Levels
Time frame: 12 weeks
HOMA-IR change
Time frame: 12 weeks
Body Weight in kg change
Time frame: 12 weeks
Total Cholesterol change
Time frame: 12 weeks
Triglycerides change
Time frame: 12 weeks
LDL-C change
Time frame: 12 weeks
HDL-C change
Time frame: 12 weeks
Number of any adverce events
Time frame: 12 weeks
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