Low-Dose Leptin and the Formerly-Obese

Phase 3

• Conditions: Obesity
• Interventions: Drug: Leptin; Behavioral: Dietary modification; Drug: T3 repletion

• Registration Number: NCT00073242
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

Our previous studies have demonstrated that there is substantial metabolic opposition to the maintenance of an altered body weight. Leptin is a protein secreted by fat cells and the circulating concentrations of leptin are directly proportional to fat mass. Leptin-deficiency is associated with severe obesity in rodents and in humans and the obesity is relieved by leptin administration. These studies examine the hypothesis that some of this metabolic opposition cto the maintenance of an altered body weight can be relieved by restoring circulating concentrations of the hormone leptin to the same range as at usual body weight in subjects who are maintaining a reduced body weight. The basic design of this study is to observe subjects at a 10% reduced body weight and then again at that reduced body weight while receiving physiological leptin or T3 supplementation.

Detailed Description

We demonstrated a substantial metabolic resistance to maintenance of altered body weight. Leptin is secreted by fat cells in circulating concentrations that are directly proportional to fat mass. Leptin-deficiency is associated with severe obesity in rodents and in humans and the obesity is relieved by leptin administration. These studies examine the hypothesis that some of this metabolic opposition cto the maintenance of an altered body weight can be relieved by restoring circulating concentrations of the hormone leptin to the same range as at usual body weight in subjects who are maintaining a reduced body weight. The basic design of this study is to observe subjects at a 10% reduced body weight and then again at that reduced body weight while receiving physiological leptin or T3 supplementation.

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2003-11-18
• Study First Submitted QC: 2003-11-18
• Study First Posted: 2003-11-19
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04
• Primary Completion: 2015-07
• Study Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
leptin repletion	Leptin	Repletion of leptin following weight loss induced by dietary modification.
leptin repletion	Dietary modification	Repletion of leptin following weight loss induced by dietary modification.
T3 repletion	Dietary modification	Repletion of T3 following weight loss induced by dietary modification.
T3 repletion	T3 repletion	Repletion of T3 following weight loss induced by dietary modification.

Primary Outcome Measures

Name	Time	Method
Effects of leptin repletion on hypometabolism/hyperphagia following weight loss	9 months per subject	Subjects are studied at usual weight and during maintenance of a 10% weight reduction while receiving either leptin repletion or a placebo in a single blind crossover design.

Trial Locations

Locations (1)

Columbia Presbyterian Medical Center; 🇺🇸 New York, New York, United States