Metformin Effects According to SLC16A11 Carrier Status
Recruiting · NCT07760883 · Observational (researchers observe without assigning treatment) · Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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
Where it is running
1 location listed.
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán - Mexico City, Mexico City, Mexico