Low-Dose Leptin and the Formerly-Obese

NCT00073242 | Unknown Phase 3 DMC

• 1 other identifier: 9631(completed)
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

leptin; obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months per subject

Study Arms (2)

leptin repletion

EXPERIMENTAL

Repletion of leptin following weight loss induced by dietary modification.

Drug: Leptin; Behavioral: Dietary modification

T3 repletion

EXPERIMENTAL

Repletion of T3 following weight loss induced by dietary modification.

Behavioral: Dietary modification; Drug: T3 repletion

Interventions

Leptin DRUG

leptin administration

Also known as: no other names

leptin repletion

Dietary modification BEHAVIORAL

Subjects lose 10% of body weight via dietary restriction

Also known as: no other name

T3 repletion; leptin repletion

T3 repletion DRUG

administer T3

Also known as: no other name

T3 repletion

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Healthy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

Columbia Presbyterian Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Leptin; Diet Therapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adipokines; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Nutrition Therapy; Therapeutics

Central Study Contacts

Elinor Naor, BS

CONTACT

212-305-7556; en2308@columbia.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2003
• First Posted: November 19, 2003
• Study Start: July 1, 2000
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

US (1)