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(JFN-0357) The Effect of Leptin Treatment on Weight Loss


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Leptin Treatment for Prevention of the Metabolic ad Endocrine Sequelae of a Decreased Caloric Intake: Studies of Patients on a Very Low Calorie Diet (JFN-0357)

Principal Investigator:
Jeffrey M. Friedman M.D., Ph.D.

Investigators:

Contact Information:
Clinical Research Support Office
Rockefeller University
1230 York Avenue
New York, NY 10021
Telephone: 800-RU-CARES
Alt. Telephone: 800-782-2737
Email: rucares@rockefeller.edu
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
This is a double blind placebo controlled clinical study designed to determine the effects of leptin on the changes that occur in the body during weight loss achieved by a very low calorie diet.



Detailed Description of Protocol:
The subject is admitted to Rockefeller University Hospital for 6-8 weeks. Baseline testing is done, then she is placed on a very low calorie liquid diet and twice daily leptin/placebo injections. She may go to work or school, but must return for evening injection. Weight and vital signs are monitored daily, and the subject receives frequent medical assessment, and weekly physical exams and laboratory monitoring.

When the subject has lost 10% of her weight, she is tested over 8 days, then enters the out patient portion of the study. She goes home on the liquid diet and injections, (self administered) and visits the outpatient clinic weekly for medical evaluation.

When 20% of the weight is lost, the subject is readmitted for a 10 day hospital stay to perform testing. Solid food is then introduced for an additional 3-4 weeks as an outpatient. Weekly clinic visits continue.

Upon completion of the study, the subject may wish to attend Bionutrition classes offered monthly at the university to maintain her weight, or to continue to lose weight in a healthy manner. Profile:
Healthy overweight adult female



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

Are 20-45 years old with a Body Mass Index of 29-45 (Calculate_BMI), and have no other illnesses

Gender:
Female

Age(s):
20-45

Children permitted to participate:
No

Potential Benefits.....
Supervised low-calorie diet

Dietary counseling

Complete physical examination

During your inpatient stay, you may continue with work or school

Private room with Cable TV, VCR



Compensation:
None