The Pathogenic Role of 11ß-hydroxysteroid Dehydrogenase in the Metabolic Syndrome - the Effect of Rosiglitazone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- changes of 11ß-HSD1 expression in adipose tissue and skeletal muscle during 8 weeks of rosiglitazone treatment
研究概览
简要总结
The purpose of this study is to determine whether the insulin sensitizing effects of rosiglitazone were accompanied by changes in 11ß-HSD1 expression and activity in different tissues. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by rosiglitazone will be analysed in several tissues.
详细描述
The PPARgamma agonist rosiglitazone (R) increases insulin sensitivity, which is comparable to the effects of a reduction in 11ß-hydroxysteroid dehydrogenase type 1 (11β-HSD1) activity in animal models. We therefore aimed to investigate whether rosiglitazone-induced insulin sensitivity is associated with changes in 11β-HSD1 activity in different tissues in subjects suffering from impaired glucose tolerance. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by rosiglitazone will be analysed in those tissue samples.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Impaired glucose tolerance
排除标准
- •Treatment with insulin
- •Orally taken antidiabetic medication, glucocorticoids or vitamin K-antagonists
- •Heart failure
- •Impaired hepatic or renal function
- •Disturbed coagulation
- •Any other endocrine disorder
研究组 & 干预措施
Rosiglitazone treatment
Rosiglitazone will be given to the subjects. All subjects will be analyzed before and after treatment
干预措施: rosiglitazone (Drug)
结局指标
主要结局
changes of 11ß-HSD1 expression in adipose tissue and skeletal muscle during 8 weeks of rosiglitazone treatment
时间窗: 8 weeks
11ß-HSD1 expression will be measured in adipose tissue and skeletal muscle
changes of hepatic 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment
时间窗: 8 weeks
11ß-HSD1 activity will be assessed by measuring conversion of cortisone to cortisol (ratio will be calculated)
changes of whole body 11ß-HSD1 activity during 8 weeks of rosiglitazone treatment
时间窗: 8 weeks
whole body 11ß-HSD1 activity will be assessed by measuring the ratio of urinary tetrahydrocortisol (THF) + alpha-tetrahydrocortisol (THF) / tetrahydrocortisone
次要结局
- changes in insulin sensitivity during 8 weeks of rosiglitazone treatment(8 weeks)
- Hormonal and metabolic changes induced by the intervention(3 months)
- changes of FGF-21 induced by the intervention(8 weeks)
- changes of free fatty acids (FFA) induced by the intervention(8 weeks)
- changes of myocellular SCD1 expression induced by the intervention(8 weeks)
- changes of myocellular long chain fatty acids (LC-FA) expression induced by the intervention(8 weeks)
研究者
Professor Joachim Spranger
Professor
Charite University, Berlin, Germany