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Role of Leptin in the Neuroendocrine and Immune Response to Fasting

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2012 by Beth Israel Deaconess Medical Center.
Recruitment status was:  Active, not recruiting
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center Identifier:
First received: August 30, 2005
Last updated: January 19, 2012
Last verified: January 2012
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 associated with fasting, which decreases leptin levels.

Condition Intervention Phase
Drug: r-metHuLeptin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans

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

Primary Outcome Measures:
  • neuroendocrine hormone levels and pulsatility and immune function [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • body composition [ Designated as safety issue: No ]
  • resting metabolic rate [ Designated as safety issue: No ]
  • autonomic function [ Designated as safety issue: No ]
  • appetite [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: October 2002
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
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 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


Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00140231

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Principal Investigator: Christos S Mantzoros, MD, DSc, FACP, FACE Beth Israel Deaconess Medical Center
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Beth Israel Deaconess Medical Center Identifier: NCT00140231     History of Changes
Other Study ID Numbers: 2002P-000049 
Study First Received: August 30, 2005
Last Updated: January 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Beth Israel Deaconess Medical Center:
immune function
energy deficiency associated with short-term fasting processed this record on December 09, 2016