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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
13
recombinant human leptin
placebo (no active drug)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cortisol
Time frame: four days
ACTH Mean Level
Response of ACTH to leptin administration in fed and fasting state from baseline was measured
Time frame: 4 days
Immune Function CD3 Count
Time frame: 4 days
%Fat Mass
Time frame: four days
(RMR)
Resting Metabolic rate using calorimetry
Time frame: four days
Autonomic Function
aldosterone level were measured on day 4 in response to leptin in fed and fasting states and compared with baseline level on day 1
Time frame: four days
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