Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
NCT Number: NCT00140231
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.
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Notify Me18 year–30 year
All sexes
Interventional
Phase 1 / Phase 2
Boston, Massachusetts, 02215, United States
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
recombinant human leptin
Other names: metreleptin
placebo (no active drug)
Time frame: four days
Time frame: 4 days
Response of ACTH to leptin administration in fed and fasting state from baseline was measured
Time frame: 4 days
Time frame: four days
Time frame: four days
Resting Metabolic rate using calorimetry
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
Beth Israel Deaconess Medical Center
Other
Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans
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