NCT00784433已完成3 期
Cardiovascular and Metabolic Effects of Moderate Alcohol Consumption in Type 2 Diabetes
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 主要终点
- Glycemic control
研究概览
简要总结
Moderate alcohol may be beneficial for diabetics
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
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of type 2 diabetes
- •Male or female alcohol abstainers (not more than 1 drink/week)
- •Age between 40-75 yrs
- •Clinically stable, with no history of stroke or myocardial infarction or major surgery within the previous 3 months
排除标准
- •The use of RI or short-acting analog insulin/ pump therapy. Patients on 1-2 injections per day of NPH or long-acting analogs will be eligible for inclusion
- •Triglycerides > 500 mg/dL
- •HbA1c<7 or > 10%
- •Serum creatinine > 2 mg/dl
- •Liver dysfunction (greater than 2-fold elevation of ALT or and 3-fold elevation of AST)
- •Evidence of severe diabetes complications (such as proliferative retinopathy or overt nephropathy)
- •Autonomic neuropathy manifested as postural hypotension or hypoglycemia unawareness
- •Patients with chronic hepatitis (C,B)
- •Use of drugs that might significantly interact with alcohol such as sedatives, antihistamines, and anti-coagulants
- •Presence of active cancer, or chemotherapy within the past 3 years
- •Major illness that may require hospitalization
- •A high potential of addictive behavior based on physician's assessment or personal or family history of addiction, alcoholism, or alcohol abuse
- •Pregnant or lactating woman
- •Participation in another trial with active intervention
研究组 & 干预措施
control
Placebo Comparator
干预措施: alcohol (Dietary Supplement)
alcohol 1
Experimental
干预措施: alcohol (Dietary Supplement)
alcohol 2
Experimental
干预措施: alcohol (Dietary Supplement)
结局指标
主要结局
Glycemic control
时间窗: 6 months
次要结局
- CVD status(6 months)
研究者
Iris Shai
Iris Shai
Ben-Gurion University of the Negev
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