NCT01115712已完成1 期
A Randomized Clinical Trial to Measure the Effect of Pioglitazone on Insulin Sensitivity in Healthy Overweight and Obese Males
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing.
研究概览
简要总结
The purpose of this study is to evaluate whether 30 mg of pioglitazone administered once daily for up to 28 days to healthy overweight and obese subjects will lead to a significant change in insulin sensitivity, measured in the setting of a hyperinsulinemic euglycemic clamp
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subject has a BMI of greater than 28 kg/m^2 and less than or equal to 38 kg/m^2
- •Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months
- •Subject is willing to avoid major dietary changes for the duration of the study
排除标准
- •Subject has history of diabetes (Type 1, Type 2 or steroid-induced)
- •Subject has a history of hypersensitivity to pioglitazone or other thiazolidinediones
- •Subject has a history of liver disease, other than non-alcoholic fatty liver disease or non-alcoholic steatohepatitis
- •Subject has a history of congestive heart failure
- •Subject has a active or past history of atherosclerotic heart disease, heart failure, osteoporosis, osteopenia, recurrent bone fractures, or anemia
- •Subject has a history of stroke, chronic seizures, or major neurological disorder
- •Subject has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological or renal abnormalities or diseases
- •Subject has a history of neoplastic disease within the past 5 years
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing.
时间窗: Baseline and 28 days
Change from baseline in glucose infusion rate (M) during the high dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing
时间窗: Baseline and 14 days
次要结局
- Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 28 days of dosing.(Baseline and 28 days)
- Change from baseline in glucose infusion rate (M) during the low dose portion of the hyperinsulinemic euglycemic clamp after 14 days of dosing(Baseline and 14 days)
研究者
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