Low-Dose Leptin and the Formerly-Obese

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor:
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: April 30, 2013
Last verified: April 2013

November 18, 2003
April 30, 2013
July 2000
July 2015   (final data collection date for primary outcome measure)
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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Complete list of historical versions of study NCT00073242 on ClinicalTrials.gov Archive Site
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Low-Dose Leptin and the Formerly-Obese
Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese

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.

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Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Obesity
  • Drug: Leptin
  • Behavioral: Dietary modification
    Subjects lose 10% of body weight via dietary restriction
  • Drug: T3 repletion
  • Experimental: leptin repletion
    Repletion of leptin following weight loss induced by dietary modification.
    Interventions:
    • Drug: Leptin
    • Behavioral: Dietary modification
  • Experimental: T3 repletion
    Repletion of T3 following weight loss induced by dietary modification.
    Interventions:
    • Behavioral: Dietary modification
    • Drug: T3 repletion
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
July 2015
July 2015   (final data collection date for primary outcome measure)

Healthy

Both
19 Years to 45 Years
Yes
Contact: Elinor Naor, BS 212-305-7556 en2308@columbia.edu
United States
 
NCT00073242
9631(completed)
Yes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP