Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

Universidad de Guanajuato122 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

122

Conditions

Prediabetes

Interventions

Family and interdisciplinary approachOTHER

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.

individual approachOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Universidad de Guanajuato

León, Guanajuato, Mexico

Outcomes

Primary Outcomes

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).

Time frame: 6 months

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).

Time frame: 12 months

Secondary Outcomes

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).

Data from ClinicalTrials.gov

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