Evaluation of Kisspeptin Glucose-Stimulated Insulin Secretion With Oral Glucose Tolerance Test
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Oral Glucose Sensitivity Index (Kisspeptin-Placebo)
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 oral glucose tolerance test
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.
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During the inpatient study, the subjects will
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Undergo a 16-hour kisspeptin infusion
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Undergo an oral glucose tolerance test
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
- •over the age of 18,
- •normal pubertal development
- •stable weight for previous three months,
- •normal body mass index (BMI between 18.5-25)
- •regular menstrual cycles
- •Physical examination:
- •systolic BP < 140 mm Hg, diastolic < 90 mm Hg
- •Laboratory studies: (per Massachusetts General Hospital reference ranges)
- •normal hemoglobin
- •hemoglobin A1C < 6.5%
- •blood urea nitrogen, creatinine not elevated
- •aspartate aminotransferase, alanine aminotransferase < 3x upper limit of normal
排除标准
- •active illicit drug use,
- •history of a medication reaction requiring emergency medical care,
- •difficulty with blood draws.
- •history of chronic disease, except well controlled thyroid disease,
- •recent use of prescription medications which interfere with metabolism or reproduction (recent = within 5 half-lives of the drug). Use of levothyroxine or seasonal allergy medications is acceptable,
- •history of diabetes in a first degree relative,
- •use of contraceptive pills, patches or vaginal rings within last 4 weeks.
- •hyperlipidemia by fasting lipid panel
- •positive serum pregnancy test (for all women)
研究组 & 干预措施
Kisspeptin
• Intravenous administration of kisspeptin 112-121 x 16 hours
干预措施: Oral Glucose Tolerance Test (Diagnostic Test)
Kisspeptin
• Intravenous administration of kisspeptin 112-121 x 16 hours
干预措施: Kisspeptin (Drug)
Placebo
• Intravenous administration of placebo x 16 hours
干预措施: Oral Glucose Tolerance Test (Diagnostic Test)
Placebo
• Intravenous administration of placebo x 16 hours
干预措施: Placebo (Drug)
结局指标
主要结局
Oral Glucose Sensitivity Index (Kisspeptin-Placebo)
时间窗: 3 hours
Change in Oral glucose Sensitivity Index between kisspeptin and placebo arms in oral glucose tolerance test
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