Status:
COMPLETED
Role of Leptin in the Neuroendocrine and Immune Response to Fasting
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Conditions:
Fasting
Eligibility:
All Genders
18-30 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study will be to determine whether giving leptin (r-metHuLeptin) to a person when he or she is fasting will reverse changes in metabolism, and hormone levels, and immune function a...
Detailed Description
Leptin is a hormone secreted by fat cells under normal conditions and acts in the brain to decrease appetite and increase energy use. Leptin levels usually go down with fasting. This study will evalua...
Eligibility Criteria
Inclusion
- Healthy lean women (with body mass indices \[BMI\] \< 25 kg/m2)
- Overweight otherwise healthy men (with BMI \> 27 kg/m2)
- Overweight otherwise healthy women (with BMI \> 27 kg/m2).
Exclusion
- A history of any illness that may affect the concentrations of the hormones to be studied, e.g. infectious diseases, renal or hepatic failure, type 1 or type 2 diabetes mellitus, cancer or lymphoma, hypogonadism, malabsorption or malnourishment, hypo- or hyperthyroidism, hypercortisolism, alcoholism or drug abuse, anemia, or eating disorder
- On medications known to affect the hormones to be measured (glucocorticoids, anti-seizure medications, and thyroid hormones)
- A known history of anaphylaxis or anaphylactoid-like reactions, or a known hypersensitivity to E. coli derived proteins
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00140231
Start Date
October 1 2002
End Date
December 1 2016
Last Update
June 7 2017
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215