NCT06863922Completed
A Pilot Study of Berberine (Soloways ™) in Patients with Type 2 Diabetes Mellitus Carrying TCF7L2 Polymorphisms
Source: ClinicalTrials.gov · Last updated 7 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 20 Feb 2025
- Start date
- 3 May 2024
- Primary completion date
- 14 Aug 2024
- Lead sponsor
- S.LAB (SOLOWAYS)
- Diseases
- Type 2 diabetes
- NCT number
- NCT06863922
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 3 May 2024 to the primary completion date, 14 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Any other acute or chronic condition that, in the investigator's judgment, could compromise the patient's safety or the study's integrity.
Other
- Pregnancy or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 30 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for New Medical Technologies Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.