NCT06863922

A Pilot Study of Berberine (Soloways ™) in Patients with Type 2 Diabetes Mellitus Carrying TCF7L2 Polymorphisms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: S.LAB (SOLOWAYS) · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This pilot, genotype-stratified clinical trial aims to investigate the safety and preliminary efficacy of berberine supplementation in adult patients with type 2 diabetes mellitus (T2DM) who carry a specific high-risk TCF7L2 polymorphism (e.g., rs7903146) in the homozygous state. The study will compare improvements in glycemic control and metabolic markers between two groups: (1) homozygous carriers of the TCF7L2 "unfavorable" variant and (2) non-carriers (wild-type). It is hypothesized that berberine will yield greater reductions in HbA1c and fasting plasma glucose among homozygous carriers, potentially due to their distinct TCF7L2-mediated insulin secretion and sensitivity pathways.

Detailed description

Type 2 diabetes mellitus is driven by a combination of insulin resistance and impaired insulin secretion. Genetic polymorphisms in the transcription factor 7-like 2 (TCF7L2) gene have been strongly associated with an increased risk of T2DM, potentially through altered beta-cell function and incretin signaling. Berberine, a natural alkaloid derived from plants such as Coptis chinensis, has demonstrated hypoglycemic effects by modulating pathways like AMPK, thereby improving insulin sensitivity and glucose metabolism. This pilot trial aims to clarify whether berberine offers a more pronounced metabolic benefit to individuals homozygous for a "high-risk" TCF7L2 polymorphism by targeting their unique pathophysiological mechanisms. Results will inform future larger-scale, genotype-focused interventional trials.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Berberine	Berberine 500-1000 mg, administered 2-3 times per day for 12 weeks, in addition to standard of care
DIETARY_SUPPLEMENT	Berberine	Berberine 500-1000 mg, administered 2-3 times per day for 12 weeks, in addition to standard of care

Timeline

• Start date: 2024-05-03
• Primary completion: 2024-08-14
• Completion: 2024-10-22
• First posted: 2025-03-07
• Last updated: 2025-03-07

Locations

1 site across 1 country: Russia