Role of Growth Hormone Antagonism in Modulating Insulin Sensitivity in Subjects With Insulin Resistance But Without Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Insulin Sensitivity
研究概览
简要总结
Growth hormone is well known to cause changes in glucose regulation. People with Laron syndrome are born without the growth hormone receptor and are protected from diabetes. Mice who are engineered without the growth hormone receptor are similarly protected from diabetes. Conversely, people who have excessive amounts of growth hormone, such as patients with acromegaly, have an increased risk for type 2 diabetes. In acromegaly patients, treatment with pegvisomant, a medication that reduces insulin like growth factor-1 by blocking the growth hormone receptor, significantly improves insulin resistance. Pegvisomant has not been explored as a possibility for the treatment of type 2 diabetes or insulin resistance in people without acromegaly. In this study, the investigators hope to study the metabolic effects of pegvisomant on people who have insulin resistance but not diabetes. Pegivosmant is expected to improve insulin resistance in the liver, fat and muscle as well as decrease serum free fatty acids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18-35
- •Homeostatic model assessment - insulin resistance (HOMA-IR) >2.77
- •Able to administer daily subcutaneous injections of pegvisomant
排除标准
- •Pregnancy
- •Breastfeeding in the last 6 months
- •Liver function tests greater than 3x the upper limits of normal
- •unstable diet over the last 3 months
- •unstable weight over the last 6 months
- •unstable lipid lowering regimen
- •diabetes - type 1 or type 2
- •History of major gastrointestinal surgery
- •History of pancreatic, liver, biliary, or intestinal disease
- •Fasting blood glucose >126
- •Fasting triglycerides>500
研究组 & 干预措施
Pegvisomant arm
Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
干预措施: pegvisomant (Drug)
结局指标
主要结局
Insulin Sensitivity
时间窗: 28 days
Investigators will measure insulin sensitivity via hyperinsulinemic euglycemic clamp prior to the initiation of the study medication and then again at the end of the 28 days to evaluate the effect of pegvisomant on insulin sensitivity and reported as HOMA-IR. HOMA-IR was derived from fasting insulin and fasting glucose by the calculation: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5
次要结局
- Lipolysis(28 days)
