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Low-Dose Leptin and the Formerly-Obese

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00073242
First Posted: November 19, 2003
Last Update Posted: June 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  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
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

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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.


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
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

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.
  Eligibility

Information from the National Library of Medicine

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

Locations
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

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)
First Submitted: November 18, 2003
First Posted: November 19, 2003
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