NCT00073242

Low-Dose Leptin and the Formerly-Obese

Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Leptin	leptin administration
BEHAVIORAL	Dietary modification	Subjects lose 10% of body weight via dietary restriction
DRUG	T3 repletion	administer T3

Timeline

• Start date: 2000-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2003-11-19
• Last updated: 2015-06-04

Locations

1 site across 1 country: United States