Low-Dose Leptin and the Formerly-Obese

NCT ID: NCT00073242

Last Updated: 2015-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2015-07-31

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.

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.

Conditions

Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

leptin repletion

Repletion of leptin following weight loss induced by dietary modification.

Group Type: EXPERIMENTAL

Leptin

Intervention Type: DRUG

leptin administration

Dietary modification

Intervention Type: BEHAVIORAL

Subjects lose 10% of body weight via dietary restriction

T3 repletion

Repletion of T3 following weight loss induced by dietary modification.

Group Type: EXPERIMENTAL

Dietary modification

Intervention Type: BEHAVIORAL

Subjects lose 10% of body weight via dietary restriction

T3 repletion

Intervention Type: DRUG

administer T3

Interventions

Leptin

leptin administration

Intervention Type: DRUG

Dietary modification

Subjects lose 10% of body weight via dietary restriction

Intervention Type: BEHAVIORAL

T3 repletion

administer T3

Intervention Type: DRUG

Other Intervention Names

no other names; no other name; no other name

Eligibility Criteria

Inclusion Criteria

Healthy

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Columbia Presbyterian Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elinor Naor, BS

Role: CONTACT

en2308@columbia.edu

212-305-7556

Facility Contacts

Michael Rosenbaum, MD

Role: primary

mr475@columbia.edu

Other Identifiers

9631(completed)

Identifier Type: -

Identifier Source: org_study_id