drugset / Trial / NCT05990205

Effect of the SCL16A11 Risk Haplotype on Treatments to Prevent Type 2 Diabetes

NCT05990205 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

The goal of this randomized clinical trial is to determine the impact of the risk haplotype on SLC16A11 on early therapeutic responses in treatments to prevent T2D in Mexican mestizos with prediabetes. The main question\[s\] it aims to answer are: * Evaluate the effect of the risk haplotype on weigth loss \>3% * Evualuate the differences in lipid profiles and glycemic parameters (fasting glucose, HbA1c). Participants will be randomized into two groups: lifestyle intervention (LSI): hypocaloric diet, 25 kcal/kg of ideal weight, 45% of the total intake of carbohydrates, 30% lipids, and 25% protein sources + physical activity (\>150 min medium intensity per week), or LSI + MET (750 mg metformin twice a day). Researchers will compare carriers and non carriers of the risk haplotype of SLC16A11 to see if there are diferent treatment responses.

Timeline

Start
2018-04-17
Primary completion
2023-12-20
Completion
2024-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 750 mg —

Indications