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

NCT00710814 | Completed Phase 1 Results DMC

• 3 other identifiers: AAAC6692R21DK081050UL1RR024156
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Roux-en-Y gastric bypass; Leptin; Bariatric surgery; Overweight after Roux-en-Y gastric bypass surgery

Outcome Measures

Primary Outcomes (1)

• Weight Change (in kg.) After Each Intervention

  For the Leptin Intervention, 16 week values were compared to baseline for those who received Leptin in the first period, and 32 week values were compared to 16 week values in those who received Leptin in the second period. For the Placebo Intervention, 16 week values were compared to baseline for those who received Placebo in the first period, and 32 week values were compared to 16 week values in those who received Placebo in the second period.

  0 weeks, 16 weeks and 32 weeks

Study Arms (2)

Leptin - Placebo

EXPERIMENTAL

Leptin self-administered subcutaneously twice each day for 16 weeks, then Placebo for 16 weeks.

Drug: Leptin; Other: Placebo

Placebo - Leptin

PLACEBO COMPARATOR

Placebo self-administered subcutaneously twice each day for 16 weeks, then Leptin for 16 weeks.

Drug: Leptin; Other: Placebo

Interventions

Leptin DRUG

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

Also known as: metreleptin

Leptin - Placebo; Placebo - Leptin

Placebo OTHER

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

Leptin - Placebo; Placebo - Leptin

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ages 25-65 years who are 18 months to 15 years Roux-en-Y gastric bypass
• Current BMI of 28-50 kg/m2 and a percent total body weight loss from highest pre-surgical weight of \>20% and \<45%
• 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

You may not qualify if:

• Diabetes
• History of plastic surgery

Sponsors & Collaborators

• Columbia University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Amylin Pharmaceuticals, LLC.: collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Overweight

Interventions

Leptin; metreleptin

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adipokines; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Judith Korner, M.D., PhD
• Organization: Columbia University

jk181@cumc.columbia.edu

2123053725

Study Officials

• Judith Korner, MD,PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 4, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: July 1, 2014
• Last Updated: November 16, 2015
• Results First Posted: November 16, 2015

Record last verified: 2015-10

Locations

US (1)