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Role of Leptin in the Neuroendocrine and Immune Response to Fasting

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140231
First Posted: September 1, 2005
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Center for Research Resources (NCRR)
Amgen
Information provided by (Responsible Party):
Christos Mantzoros, Beth Israel Deaconess Medical Center
August 30, 2005
September 1, 2005
December 29, 2015
June 7, 2017
June 7, 2017
October 2002
March 2011   (Final data collection date for primary outcome measure)
  • Cortisol [ Time Frame: four days ]
  • ACTH Mean Level [ Time Frame: 4 days ]
    Response of ACTH to leptin administration in fed and fasting state from baseline was measured
  • Immune Function CD3 Count [ Time Frame: 4 days ]
neuroendocrine hormone levels and pulsatility and immune function
Complete list of historical versions of study NCT00140231 on ClinicalTrials.gov Archive Site
  • %Fat Mass [ Time Frame: four days ]
  • (RMR) [ Time Frame: four days ]
    Resting Metabolic rate using calorimetry
  • Autonomic Function [ Time Frame: four days ]
    aldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1
  • 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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Fasting
  • Drug: r-metHuLeptin
    recombinant human leptin
    Other Name: metreleptin
  • Other: placebo
    placebo (no active drug)
  • Active Comparator: Metreleptin
    r-metHuLeptin self-administered subcutaneously
    Interventions:
    • Drug: r-metHuLeptin
    • Other: placebo
  • Placebo Comparator: Placebo
    Placebo, administered in same method as active arm.
    Interventions:
    • Drug: r-metHuLeptin
    • Other: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
December 2016
March 2011   (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
Sexes Eligible for Study: All
18 Years to 30 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00140231
2002P000049
2M01RR001032-30 ( U.S. NIH Grant/Contract )
5R01DK058785-07 ( U.S. NIH Grant/Contract )
No
Not Provided
Plan to Share IPD: Undecided
Christos Mantzoros, 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 Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
May 2017

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