Low-Dose Leptin and the Formerly-Obese

Tracking Information
First Submitted Date ICMJE	November 18, 2003
First Posted Date ICMJE	November 19, 2003
Last Update Posted Date	June 4, 2015
Study Start Date ICMJE	July 2000
Estimated Primary Completion Date	July 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 30, 2013)	Effects of leptin repletion on hypometabolism/hyperphagia following weight loss [ Time Frame: 9 months per subject ]; 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.
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; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Health Services Research
Condition ICMJE	Obesity
Intervention ICMJE	Drug: Leptin leptin administration Other Name: no other names; Behavioral: Dietary modification Subjects lose 10% of body weight via dietary restriction Other Name: no other name; Drug: T3 repletion administer T3 Other Name: no other name
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: June 23, 2005)	25
Original Enrollment ICMJE	Same as current
Estimated Study Completion Date	July 2015
Estimated Primary Completion Date	July 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Healthy
Sex/Gender	Sexes Eligible for Study: All
Ages	19 Years to 45 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
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
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	June 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP