OverweightPhase 4SHAPE3NCT00928005
Evaluating the Effects of a Diet and Exercise Program in People With Type 2 Diabetes or Prediabetes: (The SHAPE3 Study)
A Phase 4 study testing Weight loss diet and Weight loss diet plus exercise in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Type 2 Diabetes
- What is being tested?
- Weight loss diet and Weight loss diet plus exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Oct 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) 25-42kg/m^2
- Type 2 diabetes or prediabetes
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Diet and Exercise in Type 2 Diabetes and Prediabetes
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.
Read the 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.
- Conditions
- Overweight, Obesity, Type 2 Diabetes, Prediabetes
- Being tested
- Weight loss diet, Weight loss diet plus exercise
- Keywords
- Weight loss diet, Exercise training, Type 2 diabetes, Prediabetes, Cardiovascular health
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight loss dietBehavioural
The weight loss diet will follow the American Diabetes Association guidelines and be nutritionally balanced with a reduced saturated fat content.
Weight loss diet plus exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Weight loss diet | Active comparator | Participants will follow a low-calorie, low-fat weight loss diet for 6 months. Receives: Behavioral: Weight loss diet |
| Weight loss diet plus exercise | Active comparator | Participants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months. Receives: Behavioral: Weight loss diet plus exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular structure and function
Measured: Measured at 6 months
Secondary outcomes (1)
Body composition
Measured: Measured at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Kerry Stewart, National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- Kerry J Stewart, EDD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00928005
- Sponsor's protocol ID
- 666
- Other IDs
- 1R01HL086026-01A2
- Acronym
- SHAPE3
- Status last verified
- Apr 2013
- First submitted
- 23 Jun 2009
- Last updated
- 4 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet and Exercise in Type 2 Diabetes and Prediabetes
- ClinicalTrials.gov ID
- NCT00928005
- Acronym / sponsor ID
- SHAPE3 / 666
- Conditions
- Overweight, Obesity, Type 2 Diabetes, Prediabetes
- Keywords
- Weight loss diet, Exercise training, Type 2 diabetes, Prediabetes, Cardiovascular health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight loss diet | Active comparator | Behavioral: Weight loss dietParticipants will follow a low-calorie, low-fat weight loss diet for 6 months. |
| Weight loss diet plus exercise | Active comparator | Behavioral: Weight loss diet plus exerciseParticipants will follow a low-calorie, low-fat weight loss diet plus participate in a supervised exercise training program for 6 months. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index (BMI) 25-42kg/m^2
- Type 2 diabetes or prediabetes
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight loss dietThe weight loss diet will follow the American Diabetes Association guidelines and be nutritionally balanced with a reduced saturated fat content. | Behavioural | Weight loss diet |
| Weight loss diet plus exerciseThe 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. | Behavioural | Weight loss diet plus exercise |
Primary outcome
Cardiovascular structure and function
Time frame: Measured at 6 months
1 secondary outcome
Body composition
Time frame: Measured at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerry J Stewart, EDD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Weight loss diet and Weight loss diet plus exercise in people with Overweight and Obesity, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular structure and function (time frame: Measured at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.