Low-Dose Leptin and the Formerly-Obese
This study is currently recruiting participants.
(see Contacts and Locations)
Verified June 2015 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00073242
First received: November 18, 2003
Last updated: June 3, 2015
Last verified: June 2015
| Tracking Information | |||||
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| First Received Date ICMJE | November 18, 2003 | ||||
| Last Updated Date | June 3, 2015 | ||||
| Start Date ICMJE | July 2000 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00073242 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Low-Dose Leptin and the Formerly-Obese | ||||
| Official Title ICMJE | Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese | ||||
| Brief 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. | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Health Services Research |
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| Condition ICMJE | Obesity | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 25 | ||||
| Estimated Completion Date | July 2015 | ||||
| Estimated Primary Completion Date | July 2015 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Healthy | ||||
| Gender | Both | ||||
| Ages | 19 Years to 45 Years (Adult) | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00073242 | ||||
| Other Study ID Numbers ICMJE | 9631(completed) | ||||
| Has Data Monitoring Committee | Yes | ||||
| Plan to Share Data | Not Provided | ||||
| IPD Description | Not Provided | ||||
| Responsible Party | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Study Sponsor ICMJE | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| Information Provided By | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | ||||
| Verification Date | June 2015 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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