Interdisciplinary and Family Intervention to Prevent Type 2 Diabetes (CARE-in-DEEP)

Universidad de Guanajuato

Status: Completed

Conditions: Prediabetes

Treatments: Other: Family and interdisciplinary approach; Other: individual approach

Study type: Interventional

Funder types: Other

Identifiers

NCT02635646

UG 1/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 122 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 2 patient groups

Family and interdisciplinary approach

Experimental group

Description:

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

Treatment:

Other: Family and interdisciplinary approach

individual approach

Active Comparator group

Description:

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

Treatment:

Other: individual approach