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Sponsors and Collaborators: |
Columbia University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Amylin Pharmaceuticals, Inc. |
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Information provided by: | Columbia University |
ClinicalTrials.gov Identifier: | NCT00710814 |
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 secreted from adipose tissue, is a regulator of food intake and energy expenditure. Administration of leptin resulted in profound weight reduction in the few reported cases of obese individuals with genetic leptin deficiency. However, most obese people have increased leptin levels. Such individuals are said to be in a "leptin-resistant" state, whereby administration of physiological concentrations of leptin are ineffective at producing significant weight reduction. Roux-en-Y gastric bypass surgery (RYGBP) is more effective than diet alone in producing long-term reduction of body weight. Yet even after surgery there is a plateau in weight loss though the individual may still be obese and have or be at risk for obesity related morbidities. We have shown that plasma leptin levels are significantly lower in women after RYGBP compared with BMI-matched controls. This state of relative hypoleptinemia or leptin insufficiency suggests that post-RYGBP individuals may be in a "leptin-sensitive" state and, thus, would undergo further weight loss when administered doses of leptin that would not normally result in significant weight reduction. This study will examine the effects of leptin administered by self-injection twice per day on body weight and endocrine function. All individuals will received leptin and placebo and different times during the 34 week study period.
Condition | Intervention | Phase |
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Overweight |
Drug: Leptin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effects of Leptin on Body Weight and Neuroendocrine Axes After Gastric Bypass |
Estimated Enrollment: | 40 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 25 Years to 60 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gerardo Febres, MD | 212-342-0281 | gjf41@columbia.edu |
United States, New York | |
Columbia University Medical Center | Recruiting |
New York, New York, United States, 10032 | |
Contact: Gerardo Febres, MD 212-342-0281 gjf41@columbia.edu | |
Contact: Judith Korner, MD, PhD 212 305-3725 jk181@columbia.edu | |
Principal Investigator: Judith Korner, MD, PhD |
Principal Investigator: | Judith Korner, MD,PhD | Columbia University |
Responsible Party: | Columbia University ( Judith Korner, MD, PhD ) |
Study ID Numbers: | Leptin after gastric bypass, R21 DK081050, UL1 RR024156 |
Study First Received: | July 1, 2008 |
Last Updated: | July 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00710814 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Roux-en-Y gastric bypass. Leptin. Bariatric surgery. Overweight after Roux-en-Y gastric bypass surgery. |
Body Weight Signs and Symptoms Overweight |
Body Weight Signs and Symptoms Overweight |