Trial record 9 of 56 for:    Open Studies | Exclude Unknown | obesity and nutrition | NIDDK

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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Health Services Research
Official Title: Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese

Resource links provided by NLM:


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 ] [ 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.


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 Behavioral: Dietary modification
Subjects lose 10% of body weight via dietary restriction
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
Drug: T3 repletion

  Eligibility

Ages Eligible for Study:   19 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Healthy

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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)
Study First Received: November 18, 2003
Last Updated: April 30, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
leptin
obesity

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014