Pharmacokinetics of Leptin Administration During Fasting

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00140205
First received: August 30, 2005
Last updated: February 18, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Energy Deficiency Due to Short-term Fasting
Drug: r-metHuLeptin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pharmacokinetics of Leptin Administration During Fasting

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • leptin pharmacokinetic parameters

Secondary Outcome Measures:
  • neuroendocrine hormone levels
  • adipokine hormone levels
  • cytokine levels

Estimated Enrollment: 20
Study Start Date: February 2001
Estimated Study Completion Date: December 2013
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
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

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00140205

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

Additional Information:
No publications provided by Beth Israel Deaconess Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00140205     History of Changes
Other Study ID Numbers: 2001-P-000260
Study First Received: August 30, 2005
Last Updated: February 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
leptin
fasting
pharmacokinetics

ClinicalTrials.gov processed this record on September 18, 2014