Conditions: Fasting
Keywords: leptin fasting reproductive neuroendocrine immune function energy deficiency associated with short-term fasting
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 13
Healthy volunteers: yes

Brief summary:
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.

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

Arms:
arm 1: r-metHuLeptin self-administered subcutaneously arm 2: Placebo, administered in same method as active arm.

Interventions: intervention 1: r-metHuLeptin intervention 2: placebo
Intervention descriptions: intervention 1: recombinant human leptin intervention 2: placebo (no active drug)

Protocol document: