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Trial of Leptin Administration After Roux-en-Y Gastric Bypass
This study is currently recruiting participants.
Verified by Columbia University, July 2008
First Received: July 1, 2008   Last Updated: July 3, 2008   History of Changes
Sponsors and Collaborators: Columbia University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Amylin Pharmaceuticals, Inc.
Information provided by: Columbia University
ClinicalTrials.gov Identifier: NCT00710814
  Purpose

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
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

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 ]

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)
Intervention Details:
    Drug: Leptin
    Leptin or placebo self-administered subcutaneously twice each day for 34 weeks.
  Eligibility

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00710814

Contacts
Contact: Gerardo Febres, MD 212-342-0281 gjf41@columbia.edu

Locations
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            
Sponsors and Collaborators
Columbia University
Amylin Pharmaceuticals, Inc.
Investigators
Principal Investigator: Judith Korner, MD,PhD Columbia University
  More Information

No publications provided

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

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

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Overweight

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Overweight

ClinicalTrials.gov processed this record on September 11, 2009