Diabetes MellitusNCT06863922
A Pilot Study of Berberine (Soloways ™) in Patients with Type 2 Diabetes Mellitus Carrying TCF7L2 Polymorphisms
A study testing Berberine in people with Diabetes Mellitus, run by S.LAB (SOLOWAYS) at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Berberine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- 3 May 2024to 22 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Berberine
- Keywords
- diabetes mellitus, type 2 diabetes, supplements, genetics, berberine, HbA1c
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDietary supplement
Berberine 500-1000 mg, administered 2-3 times per day for 12 weeks, in addition to standard of care
BerberineDietary supplement
Berberine 500-1000 mg, administered 2-3 times per day for 12 weeks, in addition to standard of care
| Study group | Role | What they receive |
|---|---|---|
| TCF7L2 Homozygous Variant Cohort | Experimental | Not described Receives: Dietary Supplement: Berberine |
| Non-Variant (Control) Cohort | Active comparator | Not described Receives: Dietary Supplement: Berberine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Glycated Hemoglobin (HbA1c)
Measured: 12 weeks
Change in Fasting Plasma Glucose (FPG)
Measured: 12 weeks
Secondary outcomes (7)
Change in HOMA-IR (Insulin Resistance Index)
Measured: 12 weeks
Number of Adverse Events
Measured: 12 weeks
Change in Lipid Profile Triglyceride
Measured: 12 weeks
Change in Lipid Profile LDL-C
Measured: 12 weeks
Change in Lipid Profile HDL-C
Measured: 12 weeks
Change in Body Weight or Body Mass Index (BMI)
Measured: 12 weeks
Change in Patient-Reported Quality of Life as Measured by the World Health Organization
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start3 May 2024
- Primary completion14 Aug 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- S.LAB (SOLOWAYS)
- Sponsor type
- University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863922
- Sponsor's protocol ID
- SW020
- Status last verified
- Mar 2025
- First submitted
- 20 Feb 2025
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Berberine (Soloways ™) in Patients with Type 2 Diabetes Mellitus Carrying TCF7L2 Polymorphisms
- ClinicalTrials.gov ID
- NCT06863922
- Acronym / sponsor ID
- SW020
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes mellitus, type 2 diabetes, supplements, genetics, berberine, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- S.LAB (SOLOWAYS)University, hospital or other
- Collaborators
- Center for New Medical Technologies, Novosibirsk, Russia
- Study start
- 3 May 2024 (actual)
- Primary completion
- 14 Aug 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCF7L2 Homozygous Variant Cohort | Experimental | Dietary Supplement: Berberine |
| Non-Variant (Control) Cohort | Active comparator | Dietary Supplement: Berberine |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BerberineBerberine 500-1000 mg, administered 2-3 times per day for 12 weeks, in addition to standard of care | Dietary supplement | Non-Variant (Control) Cohort |
| BerberineBerberine 500-1000 mg, administered 2-3 times per day for 12 weeks, in addition to standard of care | Dietary supplement | TCF7L2 Homozygous Variant Cohort |
Primary outcome
Change in Glycated Hemoglobin (HbA1c)
Time frame: 12 weeks
Change in Fasting Plasma Glucose (FPG)
Time frame: 12 weeks
7 secondary outcomes
Change in HOMA-IR (Insulin Resistance Index)
Time frame: 12 weeks
Number of Adverse Events
Time frame: 12 weeks
Change in Lipid Profile Triglyceride
Time frame: 12 weeks
Change in Lipid Profile LDL-C
Time frame: 12 weeks
Change in Lipid Profile HDL-C
Time frame: 12 weeks
Change in Body Weight or Body Mass Index (BMI)
Time frame: 12 weeks
Change in Patient-Reported Quality of Life as Measured by the World Health Organization
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berberine in people with Diabetes Mellitus, run by S.LAB (SOLOWAYS) at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Glycated Hemoglobin (HbA1c) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2025; AzTrials last refreshed its copy on 7 Nov 2026.