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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kerry Stewart, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00928005
First received: June 23, 2009
Last updated: April 1, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Type 2 Diabetes
Prediabetes
Behavioral: Weight loss diet
Behavioral: Weight loss diet plus exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Diet and Exercise in Type 2 Diabetes and Prediabetes

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Cardiovascular structure and function [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: Measured at 6 months ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: July 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Weight loss diet
Participants will follow a low-calorie, low-fat weight loss diet for 6 months.
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.
Active Comparator: Weight loss diet plus exercise
Participants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months.
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.

Detailed Description:

Type 2 diabetes and prediabetes are conditions that are largely caused by excess weight and physical inactivity. These conditions have adverse effects on heart and blood vessel structure and function, including left ventricular diastolic dysfunction, endothelial vasodilator dysfunction, and increased vascular stiffness, each of which increase the risk of cardiovascular disease. Reducing the amount of calories consumed and increasing physical activity are both important factors for losing weight, increasing fitness, and improving blood glucose control. However, little research has been conducted on the combined effects of diet and exercise on general and abdominal obesity, fitness, heart and blood vessel structure and function, and heart disease risk factors. The purpose of this study is to determine whether people who follow a diet program plus an exercise program experience better improvements in body composition and cardiovascular health than people who follow only a diet program.

This study will enroll people who are overweight or obese and have type 2 diabetes or prediabetes. Participants will attend a baseline study visit and complete blood pressure measurements; muscle strength measurements; a treadmill test to evaluate cardiovascular fitness; an echocardiogram to obtain images of the heart; tests to measure blood vessel function; a dual energy x-ray absorptiometry (DEXA) scan to measure body fat, muscle tissue, and bone density; questionnaires to assess physical activity levels, quality of life, and mood; and a blood collection. A portion of blood will be stored for future genetic testing. Women will also provide a urine sample for pregnancy testing. Participants will also keep a food diary for 3 days. Participants will then be randomly assigned to either a weight loss diet group or a weight loss diet plus exercise group. All participants will attend study visits with a dietitian for weight loss counseling once a week during Months 1 and 2, and every other week in Months 3 through 6. At each of these visits, participants' weight will be measured. Blood pressure measurements will also occur at least once a month.

Participants who are assigned to the diet plus exercise group will also attend a supervised exercise session three times a week for 6 months. Each session will last 1 to 1 ½ hours and will include aerobic exercise and weight training. Participants who have diabetes or who are receiving medication to control their blood sugar will have their blood sugar measured before and after exercising, based on study staff recommendations. At the end of Month 6, all participants will attend a study visit for repeat baseline testing.

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index (BMI) 25-42kg/m^2
  • Type 2 diabetes or prediabetes

Exclusion Criteria:

  • Currently smokes
  • History or evidence of cardiovascular disease or other major chronic illness
  • Currently exercising regularly or following a weight loss diet
  • Uncontrolled high blood pressure
  • Any illness that would prevent participation in a moderate-intense exercise program
  • Pregnant
  • Substance abuse
  • Use of insulin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928005

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Kerry J Stewart, EDD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Kerry Stewart, Professor of Medicine, National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00928005     History of Changes
Other Study ID Numbers: 666, 1R01HL086026-01A2
Study First Received: June 23, 2009
Last Updated: April 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
Weight loss diet
Exercise training
Type 2 diabetes
Prediabetes
Cardiovascular health

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Hyperglycemia

ClinicalTrials.gov processed this record on July 23, 2014