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Completed

NCT Number: NCT02635646

Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Guanajuato

León, Guanajuato, 37670, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family and interdisciplinary approach

Other

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

Other

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.

Primary outcomes

  1. Individual Insulin Resistance and Insulin Secretion

    Time frame: 6 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 scores indicating better insulin sensitivity (better result). A value of 2.5 or less is indicative of low insulin sensitivity (worst result).

  2. Individual Insulin Resistance and Insulin Secretion

    Time frame: 12 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 outcomes

  1. Family Insulin Resistance and Insulin Secretion (Matsuda Index Measured in the Relatives of the Patients)

    Time frame: 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).

  2. Weight

    Time frame: 12 months

    Weight in the relatives of the patients

  3. 2h OGTT Glucose

    Time frame: 6 and 12 months

    Measurement of 2h post OGTT glucose

Sponsors and collaborators

Lead sponsor

Universidad de Guanajuato

Other

Collaborators

  • National Council of Science and Technology, Mexico
  • University of Texas

Registry information

Official study 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

Acronym: CARE-in-DEEP

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 21, 2015
Registry last updated
Jul 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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