Role of Leptin in the Neuroendocrine and Immune Response to Fasting

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Amgen
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00140231
First received: August 30, 2005
Last updated: January 19, 2012
Last verified: January 2012

August 30, 2005
January 19, 2012
October 2002
October 2012   (final data collection date for primary outcome measure)
neuroendocrine hormone levels and pulsatility and immune function [ Designated as safety issue: No ]
neuroendocrine hormone levels and pulsatility and immune function
Complete list of historical versions of study NCT00140231 on ClinicalTrials.gov Archive Site
  • 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 ]
  • body composition
  • resting metabolic rate
  • autonomic function
  • appetite
Not Provided
Not Provided
 
Role of Leptin in the Neuroendocrine and Immune Response to Fasting
Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans

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.

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

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Fasting
Drug: r-metHuLeptin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
Not Provided
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 30 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00140231
2002P-000049
No
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Center for Research Resources (NCRR)
  • Amgen
Principal Investigator: Christos S Mantzoros, MD, DSc, FACP, FACE Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP