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Low-Dose Leptin and the Formerly-Obese

Primary Purpose

Obesity

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Leptin
Dietary modification
T3 repletion
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity focused on measuring leptin, obesity

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Healthy

Sites / Locations

  • Columbia Presbyterian Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

leptin repletion

T3 repletion

Arm Description

Repletion of leptin following weight loss induced by dietary modification.

Repletion of T3 following weight loss induced by dietary modification.

Outcomes

Primary Outcome Measures

Effects of leptin repletion on hypometabolism/hyperphagia following weight loss
Subjects are studied at usual weight and during maintenance of a 10% weight reduction while receiving either leptin repletion or a placebo in a single blind crossover design.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2003
Last Updated
June 3, 2015
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00073242
Brief Title
Low-Dose Leptin and the Formerly-Obese
Official Title
Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2000 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
July 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
leptin, obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
leptin repletion
Arm Type
Experimental
Arm Description
Repletion of leptin following weight loss induced by dietary modification.
Arm Title
T3 repletion
Arm Type
Experimental
Arm Description
Repletion of T3 following weight loss induced by dietary modification.
Intervention Type
Drug
Intervention Name(s)
Leptin
Other Intervention Name(s)
no other names
Intervention Description
leptin administration
Intervention Type
Behavioral
Intervention Name(s)
Dietary modification
Other Intervention Name(s)
no other name
Intervention Description
Subjects lose 10% of body weight via dietary restriction
Intervention Type
Drug
Intervention Name(s)
T3 repletion
Other Intervention Name(s)
no other name
Intervention Description
administer T3
Primary Outcome Measure Information:
Title
Effects of leptin repletion on hypometabolism/hyperphagia following weight loss
Description
Subjects are studied at usual weight and during maintenance of a 10% weight reduction while receiving either leptin repletion or a placebo in a single blind crossover design.
Time Frame
9 months per subject

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Healthy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elinor Naor, BS
Phone
212-305-7556
Email
en2308@columbia.edu
Facility Information:
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Rosenbaum, MD
Email
mr475@columbia.edu

12. IPD Sharing Statement

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Low-Dose Leptin and the Formerly-Obese

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