Clinical trials / NCT07760883
Recruiting

Metformin Effects According to SLC16A11 Carrier Status

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…

ClinicalTrials.gov IDNCT07760883
PhaseNot Applicable
Enrollment154
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Age18 Years
SexALL
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Conditions studied

Diabetes Type 2

About this study

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.

Primary outcomes

Eligibility information

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

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-30.