NL-OMON35611已完成不适用
Sitagliptin prophylaxis for glucocorticoid-induced impairment of glucose metabolism and beta-cell function in males with the metabolic syndrome-X: a randomized, placebo controlled, double blind, 2x2 factorial designed intervention trial. - SPHINX study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. signed informed consent
- •2. caucasian male
- •3. normal day-and night rythm
- •4. metabolic syndrome (according to IDF criteria):
- •Waist > 93 cm and at least 3 of the following criteria:
- •- triglycerides > 1.7 mmol/L
- •- HDL cholesterol < 1.03 mmol/L
- •- blood pressure > 130/85 mmHg
- •- disturbed glucose tolerance (definded as: fasting plasma glucose above 5.6 mmol/L, but no diabetes [see exclusion criteria]).
排除标准
- •1. allergy for prednisolone
- •2. any other contra-indication for prednisolone use.
- •3. use of glucocorticoids in the past 3 months
- •4. Recent participation in a clinical trial
- •5. Blood donation in the past 3 months
- •6. (history of) alcohol or drugs abuse.
- •7. Not willing or able to sign the informed consent or not being able to understand the study information
- •8. serious (pulmonary, liver, kidney) diseases
- •9. history of cardiovascular disease (such as MI or CVA)
- •10. psychiatric disorder
- •11. depression
- •12. any condition that interferes with the HPA axis
- •13. malignancy
- •14. diabetes mellitus (defined as FPG * 7.0 mmol/l and/or 2hPG * 11.1 mmol/l)
- •15. other condition or usage of medication that may interfere with study endpoints of hypothesis. Eligibility will be assessed in each individual case by the research physician and internist.
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