Metformin Effects According to SLC16A11 Carrier Status

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

About this trial

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 criteria

Qualifiers

Male and female participants

Aged 18 to 65 years

Diagnosis of type 2 diabetes

Estimated glomerular filtration rate (eGFR) >60 mL/min

Disqualifiers

Participants receiving treatment with three glucose-lowering medications

Participants receiving insulin therapy

Pregnancy

Breastfeeding

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

154 Participants
are grouped into 2 trial groups