Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes

NCT02635646 | Completed Results DMC

• 1 other identifier: UG 1/2014
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Prediabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

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

  12 months

• Weight

  12 months

• 2h OGTT Glucose

  6 and 12 months

Study Arms (2)

Family and interdisciplinary approach

EXPERIMENTAL

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

individual approach

ACTIVE COMPARATOR

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

Interventions

Family and interdisciplinary approach OTHER

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.

Family and interdisciplinary approach

individual approach OTHER

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.

individual approach

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Type 2 diabetes
• Pregnancy
• Liver disease
• Renal disease

Sponsors & Collaborators

• Universidad de Guanajuato: lead
• University of Texas: collaborator
• National Council of Science and Technology, Mexico: collaborator

Study Sites (1)

Universidad de Guanajuato

León, Guanajuato, 37670, Mexico

Location

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Rodolfo Guardado-Mendoza
• Organization: University of Guanajuato

guardamen@gmail.com

Study Officials

• Rodolfo Guardado, Dr

  Universidad de Guanajuato

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Titular Profesor A

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: July 29, 2019
• Results First Posted: August 8, 2018

Record last verified: 2019-06

Locations

ME (1)