Low-Dose Leptin and the Formerly-Obese
Information source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Leptin (Drug); Dietary modification (Behavioral); T3 repletion (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Overall contact: Elinor Naor, BS, Phone: 212-305-7556, Email: en2308@columbia.edu
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.
Clinical Details
Official title: Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research
Primary outcome: Effects of leptin repletion on hypometabolism/hyperphagia following weight loss
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
Minimum age: 19 Years.
Maximum age: 45 Years.
Gender(s): Both.
Criteria:
Healthy
Locations and Contacts
Elinor Naor, BS, Phone: 212-305-7556, Email: en2308@columbia.edu
Columbia Presbyterian Medical Center, New York, New York 10032, United States; Recruiting Michael Rosenbaum, MD, Email: mr475@columbia.edu
Additional Information
Starting date: July 2000
Last updated: June 3, 2015
|