Evaluation of Kisspeptin Stimulated Insulin Secretion With Hyperglycemic Clamp
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- First Phase Insulin Secretion
研究概览
简要总结
The goal of this study is to understand how exogenous kisspeptin affects metabolism by evaluating responses to an hyperglycemic clamp
详细描述
Assignment: Each study subject will serve as their own control. The order of the visits will be randomized.
Delivery of Interventions:
Prior to the study visit, subjects will undergo a review of their medical history and screening laboratories.
During the inpatient study, the subjects will
Undergo a 16-hour kisspeptin infusion Undergo a hyperglycemic clamp
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
- •active illicit drug use,
- •history of a medication reaction requiring emergency medical care,
- •difficulty with blood draws.
- •history of hypertension, diabetes, heart disease, high cholesterol, cancer, or clotting disorders.
- •history of chronic disease that has required hospitalization
- •recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug) unless it is birth control
- •history of diabetes in a first degree relative
- •hyperlipidemia by fasting lipid panel
研究组 & 干预措施
Kisspeptin
Intravenous administration of kisspeptin 112-121 x 16 hours
干预措施: Hyperglycemic Clamp (Diagnostic Test)
Kisspeptin
Intravenous administration of kisspeptin 112-121 x 16 hours
干预措施: Kisspeptin-10 (Drug)
Placebo
Intravenous administration of placebo x 16 hours
干预措施: Hyperglycemic Clamp (Diagnostic Test)
Placebo
Intravenous administration of placebo x 16 hours
干预措施: Placebo (Drug)
结局指标
主要结局
First Phase Insulin Secretion
时间窗: 10 minutes
Average Change in First Phase Insulin Secretion Between Kisspeptin and Placebo Arms
Second Phase Insulin Secretion
时间窗: 2 hours
Average Change in Second Phase Insulin Secretion Between Kisspeptin and Placebo 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