Energy diagnosis |
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Clinical Trial: Rold of Leptin in the Neuroendocrine and Immune Response to Fasting
This study is currently recruiting patients.
Verified by Beth Israel Deaconess Medical Center August 2005
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| energy deficiency associated with short-term fasting | Drug: r-metHuLeptin | Phase I Phase II |
MedlinePlus consumer health information
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title: Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans
Secondary Outcomes: body composition; resting metabolic rate; autonomic function; appetite
Expected Total Enrollment: 24
Study start: October 2002; Expected completion: June 2008
Last follow-up: May 2004
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 evaluate the secretion of an investigational agent called leptin in lean and overweight individuals while fasting and investigate the potential role of leptin as a regulator of immune function and mediator of the neuroendocrine response to food deprivation in humans. Data derived from these studies will provide insights into the mechanisms underlying altered hormone levels and immune function in malnutrition and obesity and thus may provide the basis for future therapeutic interventions for obesity.
Comparison: fed state vs. fasting state vs. fasting + leptin state
Eligibility
Accepts Healthy Volunteers
Inclusion Criteria:
- 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 Criteria:
- a history of any illness that may affect the concentrations of the hormones to 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, eating disorder
- on medications known to affect the hormones to be measured (glucocorticoids, anti-seizure medications, thyroid hormones
- a known history of anaphylaxis or anaphylactoid-like reactions, or a known hypersensitivity to E. Coli derived proteins
Location and Contact Information
Patricia M Raciti (617) 667-8630 praciti@bidmc.harvard.edu
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Patricia M Raciti (617) 667-8630 praciti@bidmc.harvard.edu
Christos S Mantzoros, MD DSc FACP FACE, Principal Investigator
Jean L Chan, MD, Sub-Investigator
Christos S Mantzoros, MD DSc FACP FACE, Principal Investigator, Beth Israel Deaconess Medical Center
Jean L Chan, MD, Study Director, Beth Israel Deaconess Medical Center
More Information
Publications
Chan JL, Heist K, DePaoli AM, Veldhuis JD, Mantzoros CS. The role of falling leptin levels in the neuroendocrine and metabolic adaptation to short-term starvation in healthy men. J Clin Invest. 2003 May;111(9):1409-21.
Last Updated: August 31, 2005
Record first received: August 30, 2005
ClinicalTrials.gov Identifier: NCT00140231
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-06

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