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

March 4, 2025 updated by: S.LAB (SOLOWAYS)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Novosibirsk, Russian Federation, 630090
        • Center for New Medical Technologies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults (age 30-70 years) with a confirmed diagnosis of type 2 diabetes mellitus.
  • On stable doses of metformin or other standard oral antihyperglycemic agents for at least 4 weeks prior to enrollment.
  • Willingness to undergo genetic testing for TCF7L2 polymorphisms. For the Homozygous Variant Cohort: confirmed homozygous high-risk TCF7L2 polymorphism (e.g., rs7903146) prior to enrollment.
  • For the Non-Variant Cohort: confirmed wild-type TCF7L2 genotype.

Exclusion Criteria:

  • Current use of insulin therapy or recent (within 4 weeks) change in diabetic medications.

Known hypersensitivity or intolerance to berberine or related compounds.

  • Significant renal or hepatic impairment.
  • Pregnancy or breastfeeding.
  • Any other acute or chronic condition that, in the investigator's judgment, could compromise the patient's safety or the study's integrity.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Non-Variant (Control) Cohort
Dietary supplement: Berberine
Berberine 500-1000 mg, administered 2-3 times per day for 12 weeks, in addition to standard of care
Experimental: TCF7L2 Homozygous Variant Cohort
Dietary supplement: Berberine
Berberine 500-1000 mg, administered 2-3 times per day for 12 weeks, in addition to standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Glycated Hemoglobin (HbA1c)
Time Frame: 12 weeks
12 weeks
Change in Fasting Plasma Glucose (FPG)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events
Time Frame: 12 weeks
12 weeks
Change in Patient-Reported Quality of Life as Measured by the World Health Organization
Time Frame: 12 weeks
Patient-reported quality of life will be assessed using the World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF). This validated questionnaire provides scores ranging from 0 to 100 for each domain (physical health, psychological health, social relationships, and environment), where higher scores indicate a better quality of life. The outcome will be reported as the mean change in the relevant domain scores from baseline to 12 weeks.
12 weeks
Change in HOMA-IR (Insulin Resistance Index)
Time Frame: 12 weeks
12 weeks
Change in Lipid Profile Triglyceride
Time Frame: 12 weeks
12 weeks
Change in Lipid Profile LDL-C
Time Frame: 12 weeks
12 weeks
Change in Lipid Profile HDL-C
Time Frame: 12 weeks
12 weeks
Change in Body Weight or Body Mass Index (BMI)
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.LAB (SOLOWAYS)

Collaborators

Center for New Medical Technologies, Novosibirsk, Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2024

Primary Completion (Actual)

August 14, 2024

Study Completion (Actual)

October 22, 2024

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SW020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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