CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Leptin +1 moredrug
Likely dose
Leptin 0.05 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00710814
NCT00710814Phase 2Completed

Effects of Leptin on Body Weight and Neuroendocrine Axes After Gastric Bypass

Columbia University·interventional·Posted Jul 4, 2008·Updated Nov 16, 2015

In Brief

A Phase 2 clinical trial evaluating Leptin and Placebo for Overweight. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight
CountriesUnited States

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 4, 2008
Enrollment StartApr 1, 2008
Primary CompletionAug 1, 2012
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 18.0 years ago

Interventions

Leptindrug

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

Placeboother

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