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Low-Dose Leptin and the Formerly-Obese

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ClinicalTrials.gov Identifier: NCT00073242
Recruitment Status : Unknown
Verified June 2015 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Recruiting
First Posted : November 19, 2003
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Drug: Leptin Behavioral: Dietary modification Drug: T3 repletion Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese
Study Start Date : July 2000
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015
Arms and Interventions
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Arm Intervention/treatment
Experimental: leptin repletion
Repletion of leptin following weight loss induced by dietary modification.
 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
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
Other Name: no other name

Drug: T3 repletion
administer T3
Other Name: no other name


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
Healthy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00073242


Contacts
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Contact: Elinor Naor, BS 212-305-7556 en2308@columbia.edu

Locations
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United States, New York
Columbia Presbyterian Medical Center Recruiting
New York, New York, United States, 10032
Contact: Michael Rosenbaum, MD       mr475@columbia.edu   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00073242    
Other Study ID Numbers: 9631(completed)
First Posted: November 19, 2003    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
leptin
obesity
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight