Diabetes Mellitis
Conditions
Keywords
genetics, polymorphysm, supplements, berberine
Brief summary
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
DRUGMetformin
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_SUPPLEMENTBerberine
Berberine * Dose: 500 mg three times daily (1,500 mg/day total) * Formulation: standardized berberine HCl tablets * Duration: 12 weeks
Sponsors
Center for New Medical Technologies, Novosibirsk, Russia
S.LAB (SOLOWAYS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 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) | 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum Insulin Levels | 12 weeks |
| HOMA-IR change | 12 weeks |
| Body Weight in kg change | 12 weeks |
| Total Cholesterol change | 12 weeks |
| Fasting Plasma Glucose change (FPG) | 12 weeks |
| LDL-C change | 12 weeks |
| HDL-C change | 12 weeks |
| Number of any adverce events | 12 weeks |
| Triglycerides change | 12 weeks |
| Postprandial Glucose (PPG) change | 12 weeks |
Countries
Russia
Contacts
Primary ContactAndrei V Ponomarenko
Outcome results
None listed