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

NCT06863922 | Completed

• 1 other identifier: SW020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus

Keywords

diabetes mellitus; type 2 diabetes; supplements; genetics; berberine; HbA1c

Outcome Measures

Primary Outcomes (2)

• Change in Glycated Hemoglobin (HbA1c)

  12 weeks

• Change in Fasting Plasma Glucose (FPG)

  12 weeks

Secondary Outcomes (7)

• Change in HOMA-IR (Insulin Resistance Index)

  12 weeks

• Number of Adverse Events

  12 weeks

• Change in Lipid Profile Triglyceride

  12 weeks

• Change in Lipid Profile LDL-C

  12 weeks

• Change in Lipid Profile HDL-C

  12 weeks

Study Arms (2)

TCF7L2 Homozygous Variant Cohort

EXPERIMENTAL

Dietary Supplement: Berberine

Non-Variant (Control) Cohort

ACTIVE COMPARATOR

Dietary Supplement: Berberine

Interventions

Berberine DIETARY_SUPPLEMENT

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

Non-Variant (Control) Cohort

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.LAB (SOLOWAYS): lead
• Center for New Medical Technologies, Novosibirsk, Russia: collaborator

Study Sites (1)

Center for New Medical Technologies

Novosibirsk, 630090, Russia

Location

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Berberine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 7, 2025
• Study Start: May 3, 2024
• Primary Completion: August 14, 2024
• Study Completion: October 22, 2024
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)