Status:
COMPLETED
Pharmacokinetics of Leptin Administration During Fasting
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Amgen
Conditions:
Energy Deficiency Due to Short-term Fasting
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
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 lep...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00140205
Start Date
February 1 2001
End Date
December 1 2016
Last Update
November 2 2018
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215