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

NCT06863922 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-03-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Center for New Medical Technologies, Novosibirsk, Russia

    collaborator OTHER

  • S.LAB (SOLOWAYS)

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-03
Primary Completion
2024-08-14
Completion
2024-10-22

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863922 on ClinicalTrials.gov