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Low-Dose Leptin and the Formerly-Obese

NCT00073242 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-06-04

No results posted yet for this study

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

Interventions

DRUG

Leptin

leptin administration

BEHAVIORAL

Dietary modification

Subjects lose 10% of body weight via dietary restriction

DRUG

T3 repletion

administer T3

Sponsors & Collaborators

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

    lead NIH

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00073242 on ClinicalTrials.gov