Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

Prediabetes Clinical Trial

— CARE-in-DEEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02635646
• Other study ID #: UG 1/2014
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 2017

Study information

• Verified date: June 2019
• Source: Universidad de Guanajuato
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients with prediabetes (Fasting glucose 100-125mg/dl and/or 2h post OGTT glucose 140-199mg/dl)

• Family of patients with prediabetes (in case of the patients that are randomized to FAMILY APPROACH)

• Signing of the inform consent

Exclusion Criteria:

• Type 2 diabetes

• Pregnancy

• Liver disease

• Renal disease

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

Intervention

Other:
• Family and interdisciplinary approach
Family and interdisciplinary approach that includes: nutritional counseling, physical activity counseling, psychological counseling, 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.
• individual approach
individual approach that includes: nutritional and physical activity counseling in individual appointments, 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.

Locations

Country	Name	City	State
Mexico	Universidad de Guanajuato	León	Guanajuato

Sponsors (3)

Lead Sponsor	Collaborator
Universidad de Guanajuato	National Council of Science and Technology, Mexico, University of Texas

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual Insulin Resistance and Insulin Secretion	Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity (better result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result).	6 months
Primary	Individual Insulin Resistance and Insulin Secretion	Whole body insulin sensitivity as determined by the Matsuda Index was calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher values indicating better insulin sensitivity (better result, the higher the value the better the result of this variable). A value of 2.5 or less is indicative of low insulin sensitivity (worst result).	12 months
Secondary	Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients)	Whole body insulin sensitivity as determined by the Matsuda Index as calculated using the following formula: 10,000 divided by the square root of (FPI* FPG) * (xGPC* xIPC) Where FPI is fasting plasma insulin expressed as uU/ml, FPG is fasting plasma glucose expressed as mg/dL, xGPC is mean plasma glucose concentration after the load and xIPC is the mean insulin concentration after the load. Values calculated on samples taken at 0, 30, 60, 90 and 120 minutes of a 2 hour OGTT. Values typically range from 0 to 12 units with higher scores indicating better insulin sensitivity (the higher the value the better the result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result).	12 months
Secondary	Weight	Weight in the relatives of the patients	12 months
Secondary	2h OGTT Glucose	Measurement of 2h post OGTT glucose	6 and 12 months