Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Physiologic Mixed Meal Tolerance
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Beta-cell responsivity index
研究概览
简要总结
This study utilizes infusions of kisspeptin in healthy women to isolate the impact of kisspeptin on beta-cell responsivity assessed by the mixed meal tolerance test.
详细描述
Assignment: each study subject serves as their own control, and will come in timed to their cycle. The order in which they undergo the kisspeptin or placebo arms is randomized and separated by greater than two weeks to minimize variability and study-specific effects.
Delivery of Interventions:
Prior to each visit, study subjects will be asked to:
- eat at least 150 gm carbohydrates per day
- refrain from strenuous exercise
On the day of the visit, study subjects will:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
kisspeptin-10
kisspeptin infusion
干预措施: Kisspeptin-10 (Drug)
kisspeptin-10
kisspeptin infusion
干预措施: mixed meal tolerance test (Other)
placebo
placebo
干预措施: mixed meal tolerance test (Other)
结局指标
主要结局
Beta-cell responsivity index
时间窗: up to 6 months
Average beta-cell responsivity index derived from mixed meal tolerance data comparing placebo and kisspeptin arms
次要结局
未报告次要终点
研究者
Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, Harvard Reproductive Endocrine Sciences Center
Massachusetts General Hospital