MedPath

Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

Not Applicable
Completed
Conditions
Prediabetes
Registration Number
NCT02635646
Lead Sponsor
Universidad de Guanajuato
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
122
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Individual Insulin Resistance and Insulin Secretion12 months

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).

Secondary Outcome Measures
NameTimeMethod
Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients)12 months

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).

2h OGTT Glucose6 and 12 months

Measurement of 2h post OGTT glucose

Weight12 months

Weight in the relatives of the patients

Trial Locations

Locations (1)

Universidad de Guanajuato

🇲🇽

León, Guanajuato, Mexico

Universidad de Guanajuato
🇲🇽León, Guanajuato, Mexico

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