Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

Study Overview
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Brief Summary
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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
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This a randomized clinical trial designed to evaluate the efficacy of the following treatments: Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months 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.

Official Title
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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

Conditions
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Prediabetes

Intervention / Treatment
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* Other: Family and interdisciplinary approach
* Other: individual approach


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Family and interdisciplinary approach<br>Family and interdisciplinary approach: Patients in this group will receive a Family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months | Other: Family and interdisciplinary approach<br>* 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.<br>|
| Active Comparator: individual approach<br>individual approach: Patients in this group will receive individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months | Other: individual approach<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Weight | Weight in the relatives of the patients | 12 months | 
| 2h OGTT Glucose | Measurement of 2h post OGTT glucose | 6 and 12 months |