This prospective observational study will evaluate whether the SLC16A11 risk variant influences the response to metformin in adults with type 2 diabetes. Participants will be classified as carriers or noncarriers and followed for 6 months while receiving extended-release metformin titrated to the maximum tolerated dose, between 1,500 and 2,250 mg/day. The primary outcome is the change in glycated hemoglobin, with additional assessment of seven-point capillary glucose profiles, liver enzymes, visceral fat, lipid profile, and lactate concentrations. The study plans to include 154 participants to compare treatment response between both genetic groups and explore the potential value of a more personalized therapeutic approach.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* Male and female participants
* Aged 18 to 65 years
* Diagnosis of type 2 diabetes
* Estimated glomerular filtration rate (eGFR) \>60 mL/min
* Glycated hemoglobin (HbA1c) ≤8%
* Participants who are treatment-naïve, receiving metformin monotherapy, or receiving dual glucose-lowering therapy
* Participants who agree to take part in the study
Exclusion Criteria:
* Participants receiving treatment with three glucose-lowering medications
* Participants receiving insulin therapy
* Pregnancy
* Breastfeeding
* Chronic conditions such as HIV infection, cancer, or rheumatologic diseases, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA)
* Body mass index (BMI) ≥45 kg/m²
* Concurrent participation in another research study
Primary outcome measure(s)
Change in Glycated Hemoglobin (HbA1c) — Baseline, Week 12, and Week 24 Change in glycated hemoglobin (HbA1c), expressed as percentage points, from baseline to Week 12 and Week 24. Changes will be compared between participants with type 2 diabetes who are carriers and non-carriers of the SLC16A11 risk variant.
Trial sites (1)
Facility
City
Region
Status
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City
Mexico City
Recruiting
More Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran trials in Mexico
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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