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Effects of Leptin Treatment on Weight Loss

This study has been completed.
Sponsor:
Collaborators:
Weill Medical College of Cornell University
St. Luke's-Roosevelt Hospital Center
Columbia University
Information provided by:
Rockefeller University
ClinicalTrials.gov Identifier:
NCT00050791
First received: December 19, 2002
Last updated: October 18, 2010
Last verified: October 2010
  Purpose

This is a double blind placebo controlled clinical study designed to determine the effects of leptin on the changes that occur in the body during weight loss achieved by a very low calorie diet.


Condition Intervention Phase
Obesity
Drug: Leptin
Behavioral: Very Low Calorie Diet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Leptin Treatment for Prevention of the Metabolic and Endocrine Sequelae of a Decreased Caloric Intake: Studies of Patients on a Very Low Calorie Diet

Resource links provided by NLM:


Further study details as provided by Rockefeller University:

Primary Outcome Measures:
  • energy expenditure after 10% and 20% weight loss, achieved by a VLCD with or without A-100 treatment [ Time Frame: Testing period 2,3 and 4 after 10% and 20% weight loss ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endocrine and behavioral parameters [ Time Frame: testing period 2, 3 and 4. After 10% and 20% weight loss ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2001
Study Completion Date: June 2009
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VLCD and leptin
Very low calorie diet formula providing 800 calories per day and leptin treatment.
Drug: Leptin
Leptin is an adipocyte hormone that functions as an afferent signal in a feedback loop regulating body weight
Other Names:
  • A-100
  • Recombinant-methionyl Human Leptin (r-metHuLeptin)
Active Comparator: placebo
Very low calorie diet and placebo treatment
Behavioral: Very Low Calorie Diet
placebo injections

Detailed Description:

Leptin is a hormone that is produced by the fat tissue and acts on the brain. Leptin plays a key role in regulating energy balance and body weight in animals and in humans.

When a person loses weight, leptin concentration in the blood is reduced. Reduction in blood leptin levels has been found to be related to a decreased metabolic rate (the rate in which the body burns its calories), an increased appetite, and to many other physiological and hormonal changes that may lead to failure in dieting.

This study is aimed to test if maintaining leptin in the pre-diet level range will ameliorate the changes that occur in the body during weight loss. If these changes are reduced, the process of weight loss could be easier and faster when adhering to a low calorie diet.

In this study, leptin or placebo is administered by an injection under the skin, in a way that is similar to injections of insulin to diabetic patients. 50% of the subjects participating in the study are treated by leptin and 50% are treated by placebo. Blood leptin levels are maintained in the pre-diet range in leptin treated subjects by leptin treatment. Subjects treated by placebo will also lose weight if they adhere to the liquid diet provided by the Rockefeller University Bio-nutrition Department. The investigators and the participants don't know if leptin or placebo are used since this is a double blind study.

To participate in this study, subjects have to stay at the Rockefeller University Hospital as inpatients for about two months and continue the study as outpatients for 4 more months. During the outpatient period, subjects have to attend a clinic visit once a week. During the first 3 weeks of the study, subjects are introduced to a weight stabilization liquid diet. During this time, the initial weight is maintained and baseline study tests are performed. When testing is completed, a very low calorie liquid diet and leptin or placebo administration are initiated. Weight is monitored until 10% weight loss is achieved. At this time, a second testing period is performed in an inpatient setting. When testing is completed, weight loss and leptin or placebo treatment continue at home in an outpatient setting until 20% weight loss is achieved. When this period is completed, a third testing period is performed in an inpatient setting. The last month of the study is dedicated to a transition from the liquid diet to solid food, and to weight maintenance education provided by the hospital staff in an outpatient setting. A solid food weight maintenance diet is provided to participants during this period. At the end of this period, two days of testing are performed and leptin/placebo administration is discontinued.

Study testing periods are performed over 12 days in an inpatient setting and include a variety of blood draws, urine collection, and metabolic and behavioral tests that are known to be affected by weight loss.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

(1) adult females, age 25-45 with BMI 29-45, and no other acute or chronic illnesses. Pregnant women will not be permitted to participate in the study.

Exclusion Criteria:

  1. Chronic illnesses other the than mild forms illnesses related to obesity (hypertension, hyperlipidemia etc) that do not require medical treatment
  2. Diabetes Mellitus
  3. Chronic drug treatment for any medical conditions
  4. Inability to give informed consent
  5. Inability to give contact information (for outpatient follow up) including permanent residence, provide evidence of a stable living environment for the study period.
  6. Active weight reduction of more than 7 pounds in the last 3 months
  7. Weight at screening more than 6% lower than the maximal life time weight.
  8. History of bleeding or blood clotting disorders.
  9. Changes in smoking habits for the last 3 months.
  10. Pregnancy or breast feeding in women.
  11. Allergic reaction to local anesthetics
  12. History of anaphylaxis or anaphylactoid-like reactions
  13. Tendency to form scars (keloids) easily
  14. Subjects with known hypersensitivity to E Coli-derived proteins or any other component of the A-100 preparation.
  15. Irregular menses
  16. HIV and hepatitis B or C positive subjects.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00050791

Locations
United States, New York
Rockefeller University Hospital
New York, New York, United States, 10065
Sponsors and Collaborators
Rockefeller University
Weill Medical College of Cornell University
St. Luke's-Roosevelt Hospital Center
Columbia University
Investigators
Principal Investigator: Jeffrey Friedman, MD, PHD Rockefeller University
  More Information

No publications provided

Responsible Party: Jeffrey M. Friedman,, MD, PhD, Rockefeller University
ClinicalTrials.gov Identifier: NCT00050791     History of Changes
Other Study ID Numbers: JFN 0357
Study First Received: December 19, 2002
Last Updated: October 18, 2010
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Rockefeller University:
Obesity
Weightloss
Leptin
Diet
Reducing
Overweight
Fat

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014