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.
Male and female participants
Aged 18 to 65 years
Diagnosis of type 2 diabetes
Estimated glomerular filtration rate (eGFR) >60 mL/min
Participants receiving treatment with three glucose-lowering medications
Participants receiving insulin therapy
Pregnancy
Breastfeeding
Adults aged 18 to 65 years with type 2 diabetes and glycated hemoglobin (HbA1c) ≤8%. Participants may be treatment-naïve, receiving metformin monotherapy, or receiving dual glucose-lowering therapy, and must have an estimated glomerular filtration rate (eGFR) \>60 mL/min.
Cohort
Prospective
Not listed
Change in Glycated Hemoglobin (HbA1c)
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.
Change in Fasting Plasma Glucose
Change in fasting plasma glucose concentration, measured in mg/dL, from baseline to Week 12 and Week 24. Changes will be compared between participants with type 2 diabetes who are carriers and noncarriers of the SLC16A11 risk variant.
Change in Seven-Point Capillary Glucose Profile
Change in capillary glucose concentrations, measured in mg/dL, using a seven-point glucose profile: fasting, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and at bedtime. Results will be compared between SLC16A11 risk variant carriers and noncarriers.
Change in Alanine Aminotransferase (ALT)
Change in serum alanine aminotransferase concentration, measured in U/L, from baseline to Week 12 and Week 24.
Change in Aspartate Aminotransferase (AST)
Change in serum aspartate aminotransferase concentration, measured in U/L, from baseline to Week 12 and Week 24.
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