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

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 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.

Conditions

• Overweight

Interventions

DRUG

Leptin

Leptin self-administered subcutaneously at 0.05 mg/kg body weight twice each day

OTHER

Placebo

Sterile water equal in volume to that of the metreleptin dose calculated for each individual self-administered subcutaneously twice each day

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• Amylin Pharmaceuticals, LLC.

  collaborator INDUSTRY

• National Center for Research Resources (NCRR)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Judith Korner, MD,PhD · Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2012-08-31

Completion

2014-07-31

Countries

• United States

Study Locations