Recruiting
Phase 3

Low-Dose Leptin

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Code:

NCT00073242

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 19 - 45

Healthy Volunteers: Accepted

Interventions

Leptin

Dietary modification

T3 repletion

Study Details

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.

Conditions

Obesity

Study ID

NCT00073242

Start date

Jul, 2000

Status verified date

Jun, 2015

Completion date

Jul, 2015

Anticipated

Primary completion date

Jul, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 45

Healthy Volunteers: Accepted

Healthy

Study Design

Enrollment

25 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: leptin repletion

Repletion of leptin following weight loss induced by dietary modification.

experimental: T3 repletion

Repletion of T3 following weight loss induced by dietary modification.

Interventions

Leptin

leptin administration

Dietary modification

Subjects lose 10% of body weight via dietary restriction

T3 repletion

administer T3

Primary outcome measure

  • Effects of leptin repletion on hypometabolism/hyperphagia following weight loss [ Time Frame: 9 months per subject ]

Central Contacts and Locations

Central contacts

Locations

Columbia Presbyterian Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Michael Rosenbaum, MD

mr475@columbia.edu

More Information

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Last update posted

Jun 4, 2015

Last verified

Jun, 2015

Keywords

  • leptin
  • obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) on 2015-06-04.