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(LNE-0673) Dietary Interventions for Insulin Resistance

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Isocaloric Dietary Interventions for Insulin Resistance and the Metabolic Syndrome

Principal Investigator:
Lisa M. Neff M.D.

Jeanne Walker ANP-C
Jan L. Breslow M.D.

Contact Information:
Clinical Research Support Office
1230 York Avenue
New York, NY 10065
Telephone: 1-800-RUCARES
Alt. Telephone: 1-800-782-2737
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
Excess body weight has been associated with an increased risk of a number of metabolic abnormalities, including:
- high blood sugar (either prediabetes or diabetes)
- insulin resistance (when the body becomes less sensitive to the blood sugar lowering hormone insulin, and more of the hormone is needed to keep blood sugar levels under control)
- high triglycerides (a type of fat in the bloodstream)
- low HDL cholesterol (or “good” cholesterol)
- high blood pressure
- excess fat in the abdomen

These abnormalities can increase your chances of having heart disease and other serious medical problems. Individuals can have several of these abnormalities at the same time, a situation which is often called the “metabolic syndrome.” Dietary changes, physical activity, and weight loss are often recommended for people with the metabolic syndrome, because they can lead to improvements in each of the abnormalities described above. However, the best type of diet for people with the metabolic syndrome is not known. This study is testing the effects of three different weight maintenance diets.

Detailed Description of Protocol:
This study includes a brief outpatient phase and a 32-day (+/- 6 days) inpatient admission. During this study, you will undergo a variety of tests and procedures. More information will be provided before your first visit.
During the inpatient admission, you will be required to sleep at night at the Rockefeller University Hospital (RUH) and to consume at least two of your meals at the hospital each day. You must be present for all scheduled tests and procedures. If you are not required to be present at the hospital for a test or procedure, the researchers may give you a “pass,” which allows you to leave RUH (to go to school, work, etc.) during days and evenings. If you are away from the hospital on a “pass” during a mealtime, you will be given prepared food to take with you.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- Non-smoking men and women ages 18-65
- Female partcipants must be either post-menopausal OR be taking continuous birth control and not receiving regular periods
- BMI at or above 27
- Willingness to consume only study food and drink during the study



Children permitted to participate:

Potential Benefits.....
During this study, you will have a full physical exam and multiple blood tests during the study. If any abnormalities are uncovered during testing, you will be made aware and a copy of the standard New York-certified laboratory tests will be made available to you. If you decide to participate in the study, you will be provided with all your food and caloric beverages for 32 days. At the end of the study, you will be provided with information about healthy food choices, physical activity, and other lifestyle changes which can help improve the metabolic syndrome and reduce your chances of heart disease, diabetes, and other weight-related medical conditions.
If you are randomly assigned to the DASH diet or the low GI diet, you may experience improvements in some metabolic parameters, including blood pressure, insulin sensitivity, blood sugar control, cholesterol levels, and markers of heart disease risk.
In addition, your participation in this study will help us to learn more about the best kind of diet for people with the metabolic syndrome. This study may lead to advances in our understanding of the role of diet in health. You and others may benefit from this knowledge in the future.

Compensation is provided.