Effects of Leptin Treatment on Weight Loss

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rockefeller University
• Collaborators: Columbia University; St. Luke's-Roosevelt Hospital Center; Weill Medical College of Cornell University

Criteria

Inclusion Criteria:

(1) adult females, age 25-45 with BMI 29-45, and no other acute or chronic illnesses. Pregnant women will not be permitted to participate in the study.

Exclusion Criteria:

1. Chronic illnesses other the than mild forms illnesses related to obesity (hypertension, hyperlipidemia etc) that do not require medical treatment

2. Diabetes Mellitus

3. Chronic drug treatment for any medical conditions

4. Inability to give informed consent

5. Inability to give contact information (for outpatient follow up) including permanent residence, provide evidence of a stable living environment for the study period.

6. Active weight reduction of more than 7 pounds in the last 3 months

7. Weight at screening more than 6% lower than the maximal life time weight.

8. History of bleeding or blood clotting disorders.

9. Changes in smoking habits for the last 3 months.

10. Pregnancy or breast feeding in women.

11. Allergic reaction to local anesthetics

12. History of anaphylaxis or anaphylactoid-like reactions

13. Tendency to form scars (keloids) easily

14. Subjects with known hypersensitivity to E Coli-derived proteins or any other component of the A-100 preparation.

15. Irregular menses

16. HIV and hepatitis B or C positive subjects.