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临床试验/ACTRN12609000448246
ACTRN12609000448246已完成4 期

Reducing Cardiovascular Risk in Type 2 Diabetes: The effect of nicotinic acid prolonged release on postprandial lipoproetin metabolism in men with type 2 diabetes.

Professor Gerald Watts0 个研究点目标入组 15 人开始时间: 2009年6月12日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
15

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
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
Male

入选标准

  • Non-smoking men aged 18-75 years with a Body Mass Index (BMI) <40kg/m2 and type 2 diabetes will be recruited. Patients will be treated with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) at a stable dose for greater than or equal to 6 weeks and will have attained a target low density lipoprotein (LDL)-cholesterol of <2.5mmol/L, fasting triglyceride <4.5mmol/L and/or high density lipoprotien (HDL)-cholesterol greater than or equal to 1.0mmol/L.

排除标准

  • Subjects with genetic hyperlipidemia (e.g. familial hyperlipidaemia (FH), type III hyperlipidaemia), proteinuria, hypothyroidism, cholelithiasis, excess alcohol intake (>30g/day), haemoglobin A1c (HbA1c) >8.5%, daytime insulin treatment, uncontrolled hypertension >150/90mmHg; fasting cholesterol >6.0mmol/L or triglyceride >4.5mmol/L, creatinemia (>150umol/L), hepatic dysfunction ( aspartate ransaminase (AST) or alanine transaminase (ALT) >3x upper limit of normal (ULN), abnormal thyroid function, muscle disorders or creatinine kinase >3xULN; major systemic illness, use of steroids or other agents that may influence lipid metabolism, including fish oils, cardiovascular event within the last 6 months, anaemia or history of gout, or gastric disorders; patients on hypocaloric diets, lactose intolerance or intolerance to cream and eggs.

研究者

发起方
Professor Gerald Watts

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