NCT05990205CompletedPhase 2
Effect of the SCL16A11 Risk Haplotype on Treatments to Prevent Type 2 Diabetes
Effect of the Genetic Variants Typical of the Mestizo Population That Confer Risk of Having Metabolic Diseases on the Response to Common Treatments (Diet, Physical Activity, Metformin, Exercise).
Source: ClinicalTrials.gov · Last updated 24 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 437 (actual)
- First submitted
- 18 Jul 2023
- Start date
- 17 Apr 2018
- Primary completion date
- 20 Dec 2023
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Diseases
- Type 2 diabetes
- NCT number
- NCT05990205
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 437
- From 17 Apr 2018 to the primary completion date, 20 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic diseases
Lab values
- Chronic use of medications that altered plasma glucose levels.
Other
- Pregnancy
Who the study is looking for
- Mexican mestizos
- At least one prediabetes criteria according to the American Diabetes Association: fasting glucose between 100-124 mg/dL, Glycosylated hemoglobin (HbA1c) between 5.7-6.4, and 2-hour blood sugar between 140 mg/dl-199 mg/dl after an oral load of 75g of glucose) (1);
- Age ranged between 18-65 years
- Overweight or obesity (BMI between 25.0 - 40 kg/m2).
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.