Impact of Unacylated Ghrelin on Beta-cell Function in Humans
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- acute insulin release (AIRg)
研究概览
简要总结
Use of human unacylated ghrelin (UAG, also called des-octanoyl ghrelin) to study physiology in healthy subjects. The proposed research is an investigator-initiated study funded by the National Institutes of Health designed to examine the effect of physiologic levels of UAG on the regulation of glucose homeostasis as well as beta cell function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy men and women. Only premenopausal women who are using an adequate method of contraception at Screening and who agree to continue the contraception during the study will be included. Male subjects do not need to use on birth control.
- •Ages between 18 and 50 years, inclusive.
- •BMI between 18.5 and 29.9 kg/m2, inclusive
排除标准
- •History or clinical evidence of impaired fasting glucose or impaired glucose tolerance or diabetes mellitus, myocardial infarction, history or symptoms of congestive heart failure, history of cancer or anorexia nervosa, history or active liver or renal disease (AST or ALT >2x upper limits of normal, calculated glomerular filtration rate [GFR] <60).
- •A baseline resting systolic blood pressure of less than 100 mm Hg.
- •History of growth hormone deficiency or excess disorders (acromegaly, pituitary gigantism, panhypopituitarism); history of adrenal insufficiency or Cushing's disease/syndrome; history of neuroendocrine tumors.
- •Anemia defined as hematocrit <33%.
- •Use of medications that alter insulin sensitivity: niacin, glucocorticoids, metformin, thiazolidinediones, exenatide, or atypical anti-psychotics.
- •Pregnancy or lactation.
- •BMI <18 kg/m2 or BMI >30 kg/m2; fasting plasma glucose >100 mg/dl and/or 2 hr plasma glucose >140 mg/dl on a 75 g oral glucose tolerance test.
- •Electrocardiogram (ECG) abnormalities: specifically, myocardial ischemia, previous myocardial ischemia, atrial fibrillation, second or third degree heart block and complete right or left bundle branch block.
- •Females who are on progesterone-only contraception and those who have irregular menses.
研究组 & 干预措施
decaylated ghrelin
UAG (4.0 µg/kg/hr)
干预措施: unacylated ghrelin (Drug)
acyl ghrelin
AG (1.0 µg/kg/hr)
干预措施: acyl ghrelin (Drug)
combined acyl and desacyl ghrelin
the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr)
干预措施: combined acyl and desacyl ghrelin (Drug)
saline
saline
干预措施: saline (Drug)
结局指标
主要结局
acute insulin release (AIRg)
时间窗: one year
The primary outcome measure will be AIRg. This is calculated as the incremental insulin release,following IV glucose administration. (For the first ten minutes of the study visit.)
次要结局
- Insulin sensitivity(one year)
- Disposition index(one year)
- glucose tolerance(one year)
研究者
David Dalessio
Professor
University of Cincinnati