Kisspeptin Influence on Glucose Homeostasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Average difference in area under the curve of insulin in response to a mixed meal tolerance test
研究概览
简要总结
The goal of this study is to learn about how a naturally occurring hormone called kisspeptin affects blood sugar and insulin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •normal pubertal development
- •stable weight for previous three months
- •no active illicit drug use,
- •no history of a medication reaction requiring emergency medical care,
- •no difficulty with blood draws.
- •Physical examination:
- •systolic BP < 140 mm Hg, diastolic < 90 mm Hg,
- •Laboratory studies: (per MGH reference ranges)
- •normal hemoglobin, unless hypogonadal then no lower than 0.5 gm/dL below the lower limit of the reference range for normal women (as men and women with hypogonadism have lower hemoglobin levels off of treatment)
- •hemoglobin A1C < 6.5%
- •BUN, creatinine not elevated
- •AST, ALT < 3x upper limit of normal
- •negative serum pregnancy test (for all women)
- •no hyperlipidemia by fasting lipid panel
- •Additional Criteria by Study Population
- •Healthy Men:
- •normal body mass index (BMI between 18.5-25)
- •no history of chronic disease, except well controlled thyroid disease
- •no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine or seasonal allergy medications is acceptable.
- •no history of diabetes in a first degree relative.
- •Healthy Women:
- •normal body mass index (BMI between 18.5-25)
- •no history of chronic disease, except well controlled thyroid disease,
- •no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine or seasonal allergy medications is acceptable.
- •no history of diabetes in a first degree relative,
- •no use of contraceptive pills, patches or vaginal rings within last 4 weeks.
- •regular menstrual cycles
- •Postmenopausal Women:
- •body mass index (BMI between 18.5-30)
- •no history of chronic disease except thyroid disease, and osteoporosis,
- •no recent use of prescription medications which interfere with metabolism or reproduction. Use of levothyroxine, osteoporosis medications or seasonal allergy medications is acceptable,
- •no history of diabetes in a first degree relative,
- •normal activate protein C resistance screen,
- •if applicable, able to undergo appropriate washout from hormone therapy.
- •Men and Women with Impaired Glucose Tolerance (IGT):
- •diagnosis of impaired glucose tolerance by oral glucose tolerance test,
- •all medical conditions well-controlled.
- •Men and Women with Hypogonadism
- •diagnosis of hypogonadism,
- •all other medical conditions well-controlled,
- •if applicable, able to undergo appropriate washout from hormone therapy.
研究组 & 干预措施
Kisspeptin and Insulin Resistance Test
Intravenous (IV) administration of kisspeptin 112-121; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
干预措施: kisspeptin 112-121 (Drug)
Kisspeptin and Insulin Resistance Test
Intravenous (IV) administration of kisspeptin 112-121; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
干预措施: Insulin Resistance Test (Other)
Placebo and Insulin Resistance Test
IV administration of fluids that contain no study drug; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
干预措施: Insulin Resistance Test (Other)
Placebo and Insulin Resistance Test
IV administration of fluids that contain no study drug; eat a standard mixed meal or drink a standard mixed meal or 75 grams of oral glucose
干预措施: Placebo (Other)
结局指标
主要结局
Average difference in area under the curve of insulin in response to a mixed meal tolerance test
时间窗: 4 hours
Compares difference on and off kisspeptin
次要结局
- Average difference in area under the curve of glucose in response to a mixed meal tolerance test(4 hours)
- Average difference in area under the curve of glucagon-like peptide 1 in response to a mixed meal tolerance test(4 hours)
研究者
Stephanie B. Seminara, MD
Chief, Reproductive Endocrine Unit; Professor of Medicine, Harvard Medical School; Director, MGH Harvard Center for Reproductive Medicine
Massachusetts General Hospital