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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| leptin repletion | Experimental | Repletion of leptin following weight loss induced by dietary modification. |
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| T3 repletion | Experimental | Repletion of T3 following weight loss induced by dietary modification. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leptin | Drug | leptin administration |
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| 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 |
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elinor Naor, BS | Contact | 212-305-7556 | en2308@columbia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia Presbyterian Medical Center | Recruiting | New York | New York | 10032 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 20, 2026 | |
| Reset | Apr 8, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 20, 2026 | Apr 8, 2026 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D020738 | Leptin |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D054392 | Adipokines |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Dietary modification | Behavioral | Subjects lose 10% of body weight via dietary restriction |
|
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| T3 repletion | Drug | administer T3 |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |