ACTRN12611000992909撤回4 期
The effect of Galvus (vildagliptin) on post-prandial endothelial function and post-prandial hypertriglyceridaemia in individuals with Type 2 diabetes and fasting hypertriglyceridaemia, treated with statins.
Associate Professor Seng Khee Gan0 个研究点目标入组 20 人开始时间: 2011年9月16日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Outpatients with Type 2 diabetes on metformin treatment only (at doses 500mg to 1000mg twice daily).
- •HbA1c < 8%.
- •Already treated with a statin for at least 6 weeks with LDL cholesterol<2.5 mmol/L.
- •Hypertriglyceridaemia (Triglycerides > 1.7 mmol/L) on a random blood sample.
排除标准
- •Treatment with other oral diabetes medications other than metformin.
- •Treatment with insulin or exenatide.
- •HbA1c > 8%.
- •Treatment with fibrates.
- •Premenopausal females. Menopause is defined as 12 consecutive months without menstruation. If menopausal status is in question, a follicle-stimulating hormone (FSH) level of > 30 mIU/ml must be documented.
- •Primary dyslipidaemia, including the E2/E2 genotype.
- •Type III dyslipedaemia.
- •Uncontrollable hypertension: resting BP > 150/90.
- •Consumption of > 30g alcohol per week.
- •Tobacco smoking.
- •Significantly abnormal liver function (ALT or AST > 3 times ULN).
- •Creatine kinase > 3 x ULN.
- •Creatinaemia (> 150 micromols).
- •Macroproteinuria.
- •Significantly abnormal thyroid function.
- •Atrial fibrillation or significant dysrythmia.
- •Cardiovascular event in the last 6 months.
- •Gastric disorders.
- •Any other serious medical / systemic illness (e.g cancer).
- •Use of steroids or other medications that may affect lipid metabolism.
- •Psychiatric illness.
- •Allergies to eggs, cream, milk.
- •Likelihood of poor compliance to the study.
- •Likelihood of not completing the study.
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