Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Metformin, Berberine.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitis. Basic parameters: 30 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Efficacy of Metformin and Berberine Among TCF7L2 (rs7903146) TT vs. CC Genotype Carriers With Type 2 Diabetes: A Pilot Randomized Clinical Study
Overview
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.
Interventions
- Drug Metformin
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 - Dietary supplement Berberine
Berberine * Dose: 500 mg three times daily (1,500 mg/day total) * Formulation: standardized berberine HCl tablets * Duration: 12 weeks
Primary outcome measures
- Change in HbA1c [Time frame: 12 weeks]
- Change in HbA1c from baseline (CC + Berberine vs. CC + Metformin) [Time frame: 12 weeks]
Secondary outcome measures (10)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- Center for New Medical Technologies — Novosibirsk
Identifiers
NCT: NCT06911983 · SW026