Pharmacokinetics of Leptin Administration During Fasting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00140205
Recruitment Status : Active, not recruiting
First Posted : September 1, 2005
Last Update Posted : January 18, 2016
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center

Brief Summary:
The purpose of this study will be to determine the correct dose of leptin, a natural hormone secreted by the fat cells, to give to people when they are fasting and also to determine whether giving leptin to a person when he or she is fasting will reverse the changes in hormone levels that occur with fasting.

Condition or disease Intervention/treatment Phase
Energy Deficiency Due to Short-term Fasting Drug: r-metHuLeptin Phase 1

Detailed Description:

Leptin is a newly-identified hormone secreted by fat cells under normal conditions that acts in the brain to decrease appetite and increase long term energy usage. Leptin levels usually go down when people are not eating for extended periods of time. Changes in metabolism and certain hormone levels also occur with fasting. By studying the pharmacokinetics of leptin administration, we can evaluate the changes of leptin levels in response to giving different doses of leptin as well as acute changes of other hormones in response to leptin levels. Investigations such as this one have important implications for the future therapeutic use of leptin, including determining the appropriate dose of leptin to use in future studies involving leptin administration.

Comparison: subjects receiving leptin at 3 different doses in the fed state compared to the fasting state

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pharmacokinetics of Leptin Administration During Fasting
Study Start Date : February 2001
Actual Primary Completion Date : June 2004
Estimated Study Completion Date : December 2018

Primary Outcome Measures :
  1. leptin pharmacokinetic parameters

Secondary Outcome Measures :
  1. neuroendocrine hormone levels
  2. adipokine hormone levels
  3. cytokine levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy men with body mass indices (BMI) <25 kg/m2)
  • overweight otherwise healthy men with BMI > 27 kg/m2
  • healthy lean women with BMI<25 kg/m2
  • overweight otherwise healthy women with BMI > 27 kg/m2

Exclusion Criteria:

  • history of any illness that may affect the concentrations of the hormones that will be studied (such as anemia, infectious diseases, renal or hepatic failure, diabetes mellitus, cancer, lymphoma, hypogonadism, malabsorption or malnourishment, hypo or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, eating disorders)
  • on medications known to affect the hormones to be measured in this study (such as glucocorticoids, anti-seizure medications or thyroid hormones)
  • known history of anaphylaxis or anaphylactoid-like reactions or who have a known hypersensitivity to E. Coli derived proteins
  • women who are breast feeding, pregnant, or wanting to become pregnant during the next 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00140205

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Principal Investigator: Christos S Mantzoros, MD DSc FACP FACE Beth Israel Deaconess Medical Center

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Beth Israel Deaconess Medical Center Identifier: NCT00140205     History of Changes
Other Study ID Numbers: 2001-P-000260
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016

Keywords provided by Beth Israel Deaconess Medical Center: