Trial of Leptin Administration After Roux-en-Y Gastric Bypass

This study has been completed.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amylin Pharmaceuticals, LLC.
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Judith Korner, Columbia University Identifier:
First received: July 1, 2008
Last updated: December 16, 2014
Last verified: December 2014

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. The investigators 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
Drug: Leptin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Leptin on Body Weight and Neuroendocrine Axes After Gastric Bypass

Resource links provided by NLM:

Further study details as provided by Columbia University:

Primary Outcome Measures:
  • change in body weight [ Time Frame: 34 weeks ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: April 2008
Study Completion Date: July 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: leptin Drug: Leptin
Leptin or placebo self-administered subcutaneously twice each day for 34 weeks.
Placebo Comparator: placebo


Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women only.
  • Must have had Roux-en-Y gastric bypass 18 months to 10 years ago.
  • Current BMI between 28 to 44.
  • 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 Criteria:

  • Diabetes.
  • History of plastic surgery.
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Please refer to this study by its identifier: NCT00710814

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amylin Pharmaceuticals, LLC.
National Center for Research Resources (NCRR)
Principal Investigator: Judith Korner, MD,PhD Columbia University
  More Information

No publications provided

Responsible Party: Judith Korner, Associate Professor of Medicine, Columbia University Identifier: NCT00710814     History of Changes
Other Study ID Numbers: AAAC6692, R21DK081050, UL1RR024156
Study First Received: July 1, 2008
Last Updated: December 16, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Columbia University:
Roux-en-Y gastric bypass.
Bariatric surgery.
Overweight after Roux-en-Y gastric bypass surgery.

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms processed this record on October 09, 2015