DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017