Low-Dose Leptin and the Formerly-Obese

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Leptin
* Behavioral: Dietary modification
* Drug: T3 repletion


Participation Criteria
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Eligibility Criteria
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Healthy

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: leptin repletion<br>Repletion of leptin following weight loss induced by dietary modification. | Drug: Leptin<br>* leptin administration<br>* Other names: no other names;Behavioral: Dietary modification<br>* Subjects lose 10% of body weight via dietary restriction<br>* Other names: no other name;|
| Experimental: T3 repletion<br>Repletion of T3 following weight loss induced by dietary modification. | Behavioral: Dietary modification<br>* Subjects lose 10% of body weight via dietary restriction<br>* Other names: no other name;Drug: T3 repletion<br>* administer T3<br>* Other names: no other name;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of leptin repletion on hypometabolism/hyperphagia following weight loss | 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. | 9 months per subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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leptin, obesity