NCT02635646

Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

Efficacy of a Family and Interdisciplinary Intervention to Prevent Diabetes, and Effect on Family Profiles of Insulin Secretion and Insulin Resistance in Patients With Prediabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Universidad de Guanajuato · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the effect of a family and interdisciplinary approach on individual and family insulin resistance and insulin secretion in patients with prediabetes.

Detailed description

This a randomized clinical trial designed to evaluate the efficacy of the following treatments: 1. Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months 2. Individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months To improve individual and family insulin resistance and insulin secretion in patients with prediabetes. Patients will have a follow-up visit every month in the Metabolic Research Laboratory at the University of Guanajuato, Mexico, and will have a fasting measurement of lipids, glucose and insulin every 3 months, as well as 2h oral glucose tolerance test (OGTT) at basal, 6 and 12 months.

Conditions

• Prediabetes

Interventions

Type	Name	Description
OTHER	Family and interdisciplinary approach	Family and interdisciplinary approach that includes: 1. nutritional counseling, 2. physical activity counseling, 3. psychological counseling, 4. metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling.
OTHER	individual approach	individual approach that includes: 1. nutritional and physical activity counseling in individual appointments, 2. metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-12-01
• Completion: 2017-02-01
• First posted: 2015-12-21
• Last updated: 2019-07-29
• Results posted: 2018-08-08

Locations

1 site across 1 country: Mexico