NCT00140231

Role of Leptin in the Neuroendocrine and Immune Response to Fasting

Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 30 Years
• Healthy volunteers: Accepted

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

Conditions

• Fasting

Interventions

Type	Name	Description
DRUG	r-metHuLeptin	recombinant human leptin
OTHER	placebo	placebo (no active drug)

Timeline

• Start date: 2002-10-01
• Primary completion: 2011-03-01
• Completion: 2016-12-01
• First posted: 2005-09-01
• Last updated: 2017-06-07
• Results posted: 2017-06-07

Locations

1 site across 1 country: United States