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

NCT05990205 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 437

Last updated 2024-05-24

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Life Style Intervention + Metformin

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) + Metformin extended release 750mg each 12 hours

BEHAVIORAL

Life Style Intervention

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)

Sponsors & Collaborators

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    lead OTHER

Principal Investigators

  • Carlos A Aguilar Salinas, PhD · Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Mexico

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05990205 on ClinicalTrials.gov