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Rold of Leptin in the Neuroendocrine and Immune Response to Fasting - Article


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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

Sponsors and Collaborators: Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Amgen
Information provided by: Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00140231

Purpose

The purpose of this study will be to determine whether giving leptin to a person when he or she is fasting will reverse changes in metabolism, and hormone levels, and immune function associated with fasting, which decreases leptin levels.
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

Further Study Details: 
Primary Outcomes: neuroendocrine hormone levels and pulsatility and immune function
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

Ages Eligible for Study:  18 Years   -   30 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00140231

Jean L Chan, MD      (617) 667-8624    jchan@bidmc.harvard.edu
Patricia M Raciti      (617) 667-8630    praciti@bidmc.harvard.edu

Massachusetts
      Beth Israel Deaconess Medical Center, Boston,  Massachusetts,  02215,  United States; Recruiting
Jean L Chan, MD  (617) 667-8624    jchan@bidmc.harvard.edu 
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

Study chairs or principal investigators

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.

Study ID Numbers:  2002P-000049
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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November 28, 2009



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