Effect of Low Dose Thiazide Diuretics on New Onset Type 2 Diabetes in Patients With Essential Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,130
- 试验地点
- 1
- 主要终点
- New onset type 2 diabetes (WHO criteria 1998)
研究概览
简要总结
The purpose of DIME is to evaluate the safety (i.e. new onset of diabetes and other metabolic adverse events), efficacy and cost-effectiveness of antihypertensive treatment with low dose diuretics. The researchers' hypothesis is that use of low dose thiazide diuretics is metabolically safe when used with other appropriate antihypertensives, effective in reduction of blood pressure and cheaper than treatment without diuretics. Therefore, this study is an equivalence trial.
详细描述
There has been substantial evidence from clinical trials to support the rationale of use of thiazide diuretics in patients with essential hypertension. Diuretics may be more effective in reduction of blood pressure in Japanese patients than Caucasian because of higher salt intake. Moreover, given a large number of hypertensive population here, diuretics may be the most cost-effective antihypertensive agent. Japanese physicians, however, tend to avoid diuretics even in elderly hypertensive patients because of much concern over metabolic adverse events including new onset diabetes, which is deemed to increase cardiovascular risk. Although it is unlikely that use of low dose (12.5 mg of HCTZ or less) diuretics is associated with metabolic adverse events when they are given with any other appropriate antihypertensive agents (e.g. Ca antagonist, ACE inhibitor, ARB, K sparing diuretics) other than β-blockers, the researchers have to confirm the safety of low dose diuretics in terms of new onset diabetes in Japanese, who are assumed to be "diabetes prone" based upon thrifty gene hypothesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 30 to 79 years
- •With blood pressure being >150/>90 if they are not on any antihypertensive treatment
- •With blood pressure being >140/>90 if they are already on antihypertensive drugs
- •No history of type 2 diabetes
- •No history of gout
排除标准
- •With supine blood pressure being >200/>120
- •Patients already on antihypertensive treatment if duration of treatment and drugs used are not identified
- •Patients already on thiazide diuretics
- •With type 2 diabetes
- •With gout or hyperuricaemia (>8.0 mg/dl)
- •With hypokalemia（<3.5mmol/L）
- •With erectile dysfunction
- •With renal dysfunction (s-creatinine > 2.0 mg/dL)
- •With history of serious adverse reaction to thiazide diuretics
- •With history of stroke or myocardial infarction within 6 months
- •With history of percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) within 6 months or in whom these interventions are planned
- •With heart failure or left ventricular dysfunction (ejection fraction<40%)
- •Patients who should be on thiazide diuretics
- •With history of malignant tumor within 5 years
- •Pregnant, possibility of pregnancy, or during breast feeding
- •Patients who are deemed not eligible for this study for any reason
研究组 & 干预措施
1
Diuretics use
干预措施: Thiazide diuretics (Drug)
2
No diuretics use
干预措施: No diuretics (Drug)
结局指标
主要结局
New onset type 2 diabetes (WHO criteria 1998)
时间窗: five years
次要结局
- Treatment resistant hypokalemia less than 3.5mEq/L(five years)
- Ischemic and hemorrhagic Strokes excluding transient ischemic attacks and secondary causes(five years)
- Total death(five years)
- Blood pressure(five years)
- Hospitalization due to heart failure(five years)
- HbA1c(five years)
- Fasting blood sugar(five years)
- Myocardial infarction(five years)
- Lipid profile(five years)
- Arteriosclerosis obliterans (ASO)(five years)
- Direct Cost(five years)
- Gout (American College of Rheumatology 1997 criteria C)(five years)
研究者
Takeshi Morimoto
Professor of Medicine
Kyoto University