Role of Leptin in the Neuroendocrine and Immune Response to Fasting in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Cortisol
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Metreleptin
r-metHuLeptin self-administered subcutaneously
干预措施: r-metHuLeptin (Drug)
Metreleptin
r-metHuLeptin self-administered subcutaneously
干预措施: placebo (Other)
Placebo
Placebo, administered in same method as active arm.
干预措施: r-metHuLeptin (Drug)
Placebo
Placebo, administered in same method as active arm.
干预措施: placebo (Other)
结局指标
主要结局
Cortisol
时间窗: four days
ACTH Mean Level
时间窗: 4 days
Response of ACTH to leptin administration in fed and fasting state from baseline was measured
Immune Function CD3 Count
时间窗: 4 days
次要结局
- %Fat Mass(four days)
- (RMR)(four days)
- Autonomic Function(four days)
研究者
Christos Mantzoros
Professor of Medicine
Beth Israel Deaconess Medical Center