Effects of Human Leptin Replacement
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in Weight
研究概览
简要总结
This study will test the hypothesis that leptin contributes to the regulation of the dynamics of human endocrine function.
详细描述
The study aims to elucidate the role of leptin in the regulation of human endocrine function approached by a carefully designed, prospective clinical study of the rapidly-sampled dynamics of endocrine rhythms during the course of leptin-replacement treatment in the only three adult individuals identified in the world so far who are leptin-naive due to a functional leptin gene mutation. A study of leptin-naive subjects avoids all confounding factors and pitfalls, because the only bioactive leptin to which they will be exposed is the exogenously administered recombinant protein. Thus, this proposal will permit us to ascertain the endocrine effects of human leptin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital leptin deficiency (these are only 3 adult individuals in the world that have been identified as leptin-naïve thus far).
排除标准
- •Pregnant, trying to become pregnant, breast-feeding an infant or sexually active women, not using contraception.
- •Subjects with hemoglobin levels below 12 g/dl.
- •Subjects whose body contains a ferromagnetic implanted device that might produce a safety hazard during fMRI.
研究组 & 干预措施
Recombinant methionyl human leptin
Participants with congenital leptin deficiency will receive the Recombinant methionyl human leptin intervention subcutaneously, once a day with a dose of 0.02 to 0.04 mg/kg (adjusted according to weight loss).
干预措施: Recombinant methionyl human leptin (Drug)
结局指标
主要结局
Change in Weight
时间窗: Baseline, 107 months
次要结局
- Change in Glucose Levels(Baseline, 107 months)
研究者
Richard Bookman
Associate Professor
University of Miami