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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Columbia University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Judith Korner, Columbia University
ClinicalTrials.gov Identifier:
NCT00710814
First received: July 1, 2008
Last updated: July 31, 2012
Last verified: July 2012
  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. 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
Overweight
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 ]

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Primary Completion Date: August 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Amylin Pharmaceuticals, LLC.
Investigators
Principal Investigator: Judith Korner, MD,PhD Columbia University
  More Information

No publications provided

Responsible Party: Judith Korner, Associate Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT00710814     History of Changes
Other Study ID Numbers: AAAC6692, R21DK081050, UL1RR024156
Study First Received: July 1, 2008
Last Updated: July 31, 2012
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.

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014