Suspended

Effects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese

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What is being tested

Leptin

+ Dietary modification

+ T3 repletion

DrugBehavioral
Who is being recruted

Body Weight+2

+ Nutrition Disorders

+ Obesity

From 19 to 45 Years
See all eligibility criteria
How is the trial designed

Services Research Study

Phase 3
Interventional
Study Start: July 2000
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactElinor Naor, BS
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2000

Actual date on which the first participant was enrolled.

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.

Official TitleEffects of Low-Dose Leptin on the Metabolic/Behavioral Phenotypes of the Formerly-Obese 
NCT00073242
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ContactElinor Naor, BS
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Services Research Study

These studies look at how healthcare is delivered, managed, and organized. They aim to improve care quality, patient experience, and access to treatment.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 19 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Body WeightNutrition DisordersObesityOvernutritionOverweight

Criteria

Healthy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Repletion of leptin following weight loss induced by dietary modification.

Group II

Experimental
Repletion of T3 following weight loss induced by dietary modification.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Columbia Presbyterian Medical Center

New York, United StatesSee the location
SuspendedOne Study Center