How metformin works in people with or without the SLC16A11 risk variant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study compares metformin response between adults with type 2 diabetes who are carriers of the SLC16A11 risk variant and those who are noncarriers. Participants will receive extended-release metformin with gradual dose up to 2,250 mg/day, and will be followed for six months. Primary outcome is the change in HbA1c, with additional assessments including seven-point capillary glucose profiles, liver enzymes, visceral fat, lipid profile, and lactate concentrations. The study plans to enroll about 154 participants, all at or above 18 and up to 65 years old, with eGFR >60 mL/min and HbA1c ≤8%. This work aims to explore whether genetic variant status could inform more personalized metformin therapy in type 2 diabetes.

Why it matters

Who can join: the full rules

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's running

• Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
  Mexico City, Mexico City, Mexico Recruiting

Study contacts

• Study coordinator: Paloma Almeda Valdés, MD, PhD
• Email: paloma.almedav@incmnsz.mx
• Phone: 525554870900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.