- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00928005
Evaluating the Effects of a Diet and Exercise Program in People With Type 2 Diabetes or Prediabetes: (The SHAPE3 Study) (SHAPE3)
Diet and Exercise in Type 2 Diabetes and Prediabetes
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21224
- Johns Hopkins Bayview Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Weight loss diet
Participants will follow a low-calorie, low-fat weight loss diet for 6 months.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cardiovascular structure and function
Time Frame: Measured at 6 months
|
Measured at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Body composition
Time Frame: Measured at 6 months
|
Measured at 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kerry J Stewart, EdD, Johns Hopkins University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 666
- 1R01HL086026-01A2 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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