Low-Dose Leptin and the Formerly-Obese

National Institutes of Health (NIH)

Status and phase: Unknown; Phase 3

Conditions: Obesity

Treatments: Drug: Leptin; Behavioral: Dietary modification; Drug: T3 repletion

Study type: Interventional

Funder types: NIH

Identifiers

NCT00073242

9631(completed)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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25 participants in 2 patient groups

leptin repletion

Experimental group

Description:

Repletion of leptin following weight loss induced by dietary modification.

Treatment:

Behavioral: Dietary modification

Drug: Leptin

T3 repletion

Experimental group

Description:

Repletion of T3 following weight loss induced by dietary modification.

Treatment:

Drug: T3 repletion

Behavioral: Dietary modification