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Evaluating the Effects of a Diet and Exercise Program in People With Type 2 Diabetes or Prediabetes: (The SHAPE3 Study)

NCT00928005 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2013-04-04

No results posted yet for this study

Summary

Type 2 diabetes and prediabetes, which are mainly caused by a lack of physical activity and excess weight, put people at an increased risk of cardiovascular disease. This study will compare the effects of a weight loss diet versus a weight loss diet plus an exercise program on body composition and cardiovascular factors that are early predictors of future cardiovascular disease in overweight and obese people with type 2 diabetes and prediabetes.

Conditions

Interventions

BEHAVIORAL

Weight loss diet

The weight loss diet will follow the American Diabetes Association guidelines and be nutritionally balanced with a reduced saturated fat content.

BEHAVIORAL

Weight loss diet plus exercise

The supervised exercise training sessions will take place three times a week for 6 months. Each session will last 1 to 1 ½ hours and will include aerobic exercise and weight training.

Sponsors & Collaborators

Principal Investigators

  • Kerry J Stewart, EDD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928005 on ClinicalTrials.gov