Status:
COMPLETED
Trial of Leptin Administration After Roux-en-Y Gastric Bypass
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amylin Pharmaceuticals, LLC.
Conditions:
Overweight
Eligibility:
FEMALE
25-65 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a pilot and feasibility study to examine a novel intervention using leptin in weight-reduced individuals who have undergone bariatric surgery but still remain obese. Leptin, a peptide hormone ...
Detailed Description
Metreleptin will be self-administered by subcutaneous injection at 0.05 mg/kg body weight twice per day (i.e. at 8 am and 8 pm). This dose was chosen because it would not be expected to cause substant...
Eligibility Criteria
Inclusion
- Women ages 25-65 years who are 18 months to 15 years Roux-en-Y gastric bypass
- Current BMI of 28-50 kg/m2 and a percent total body weight loss from highest pre-surgical weight of \>20% and \<45%
- Must live in the vicinity of New York City to comply with 11 study visits over 34 weeks
- Must be willing to self-inject study drug twice per day
Exclusion
- Diabetes
- History of plastic surgery
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00710814
Start Date
April 1 2008
End Date
July 1 2014
Last Update
November 16 2015
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032