|
|
View Clinical Trial (Medical Research Study)
|
Evaluating the Effects Two Diets Combined With Exercise in Persons With Abdominal Obesity (The SHAPE5 Study) - NCT00990457-21224 (Clinical Trial 368360)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy368360.aspx
|
** Please review additional "Nearby Studies" on right ----->
|
|
 |
 |
|
| City: |
|
Baltimore |
|
State:
|
|
MD |
| Zip Code: |
|
21224 |
| Conditions: |
|
Overweight - Obese - Sedentary - Abdominal Obesity |
| Purpose: |
|
Abdominal obesity, which is affected 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 two different dietary approaches to weight loss, each combined with exercise, for their
effects on cardiovascular factors that are early predictors of future cardiovascular disease
in overweight and obese people with excessive weight around their waist. The two diets are a
low-carbohydrate versus a more traditional low-fat, low calorie diet.
|
| Study summary: |
|
Abdominal obesity is a condition that is largely influenced by a poor diet and physical
inactivity. This condition has 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 comparing different
diet approaches combined with exercise for their effects 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 low-carbohydrate diet or a
low-fat, low-calorie diet, each combined with a supervised experience similar improvements
in cardiovascular and in body composition and health.
This study will enroll people who are overweight or obese and abdominal obesity, defined as
a waist to hip ratio greater than 1, or a waist size of 40" or greater in men or 35" or
greater in women. Participants will attend baseline study visits 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
low-carbohydrate or a low-fat, low-calorie weight loss diet, each combined with a supervised
exercise program. . The exercise program will be done three times a week for 6 months. Each
session will last 1 to 1 ½ hours and will include aerobic exercise and weight training.
All participants will attend study visits with a dietitian for weight loss counseling and
monitoring 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.
At the end of Month 6, all participants will attend a study visit for repeat baseline
testing. In addition, there will another test for vascular function, BP, weight, and waist
and hip measurements at the time a participant loses ten pounds. |
| Criteria: |
|
Inclusion Criteria:
- Ages 30-65 years old
- Body mass index (BMI) of 25-42 kg/m^2
- Waist of 35 inches or greater in women and 40 inches or greater in men; or, a
- Waist-hip ratio greater than 1.
Exclusion Criteria:
- Currently smokes
- History or evidence of cardiovascular disease or other major chronic illness
- Currently exercising regularly or following a weight loss diet
- Diabetes
- Uncontrolled high blood pressure
- Any illness that would prevent participation in a moderate-intense exercise program
- Pregnant
- Substance abuse |
|
|
|
| Study is available at: |
|
Johns Hopkins Bayview Medical Center
Baltimore, MD 21224
United States
Primary Contact:
Anita C Bacher, MSN, MPH, MA
Email: abach@jhmi.edu
Phone: 410-550-5428 |
|
|
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
|
| Trials Alerts: |
|
If you would like to be
notified of new clinical trials as they become available please
register for a free account.
|
|
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
March 16, 2010 |
Modifications to
this listing: |
|
Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
|
|
|
|
|
|
|
|