Metformin Effects According to SLC16A11 Carrier Status (NCT07760883) | Clinical Trial Compass
RecruitingNot Applicable
Metformin Effects According to SLC16A11 Carrier Status
Mexico154 participantsStarted 2020-09-23
Plain-language summary
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 participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Glycated Hemoglobin (HbA1c)
Timeframe: Baseline, Week 12, and Week 24
Trial details
NCT IDNCT07760883
SponsorInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran