Low-Dose Leptin and the Formerly-Obese
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: Leptin Behavioral: Dietary modification Drug: T3 repletion |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
| Official Title: | Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese |
- Effects of leptin repletion on hypometabolism/hyperphagia following weight loss [ Time Frame: 9 months per subject ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 25 |
| Study Start Date: | July 2000 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: leptin repletion
Repletion of leptin following weight loss induced by dietary modification.
|
Drug: Leptin
Behavioral: Dietary modification
Subjects lose 10% of body weight via dietary restriction
|
|
Experimental: T3 repletion
Repletion of T3 following weight loss induced by dietary modification.
|
Behavioral: Dietary modification
Subjects lose 10% of body weight via dietary restriction
Drug: T3 repletion
|
Eligibility| Ages Eligible for Study: | 19 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Healthy
Contacts and Locations| Contact: Elinor Naor, BS | 212-305-7556 | en2308@columbia.edu |
| United States, New York | |
| Columbia Presbyterian Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Michael Rosenbaum, MD mr475@columbia.edu | |
More Information
No publications provided
| Responsible Party: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| ClinicalTrials.gov Identifier: | NCT00073242 History of Changes |
| Other Study ID Numbers: | 9631(completed) |
| Study First Received: | November 18, 2003 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration |
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
|
leptin obesity |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013