Moderate Alcohol Intake Among Patients With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 主要终点
- Glucose
研究概览
简要总结
Our specific aim is to explore the effect of moderate alcohol intake on parameters of glycemic index and lipid profile among patients with type 2 diabetes.
详细描述
Successful long-term control of hyperglycemia decreases the risk for diabetic complications . Although a family history of diabetes is an established risk factor for type 2 diabetes, lifestyle factors also play an important role in its cause . However, physicians are poorly informed about how their patients' alcohol use affects risk for or management of diabetes. Moderate alcohol consumption has been associated with lower risk of both cardiovascular disease and type 2 diabetes, and is also linked to lower cardiovascular risk among type 2 diabetics. Potential mechanisms have focused primarily on lipid metabolism, coagulation, fibrinolysis, and insulin sensitivity. A recent systematic review of the literature to assess the effect of alcohol consumption on risk for and management and complications of diabetes mellitus suggests that moderate alcohol consumption is associated with a decreased risk for diabetes, whereas heavy alcohol consumption may be associated with an increased risk. Our aim is to assess the effect of moderate alcohol intake on glycemic control and cardiovascular disease mediators among patients with type 2 diabetes.
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
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
- •Age between 40-75 yrs.
- •Alcohol abstainers (less than or equal to 1 drink/week)
- •Established diagnosis of type 2 diabetes.
- •Clinically stable, with no stroke or MI within the last 3 months and no major surgery within the last 3 months.
排除标准
- •Taking Insulin >2 injections /day, or with insulin pump.
- •TGs>500 mg/dL.
- •HbA1c >10%
- •Serum creatinine > 2 mg/dl
- •Liver dysfunction (above 2 fold level of ALT and/or AST enzymes)
- •Evidence of severe diabetes complications (such as proliferative retinopathy or renal disease).
- •Patients with autonomic neuropathy manifested as postural hypertension and/or hypoglycemia unawareness.
- •Using drugs that might significantly interact with moderate alcohol. List of drugs will be obtained from pharmacology expert.
- •Presence of active cancer, receiving or had received chemotherapy in last 3 years.
- •Suffering a major illness that might probably require hospitalization (upon physician's evaluation).
- •Clinically assessed as having high potential of addictive behavior as judged by a validated clinical assessment and/or personal or family history of addiction, alcoholism or alcohol abuse.
- •Severe symptoms during run-in as assessed by the physician.
- •Pregnant or lactating women.
- •Participation in another trial in which active intervention is being received.
研究组 & 干预措施
Mediterranean diet + red wine
干预措施: alcohol (Drug)
Mediterranean diet + white wine
干预措施: alcohol (Drug)
Mediterranean diet+ mineral water
干预措施: alcohol (Drug)
结局指标
主要结局
Glucose
时间窗: Differance between 3 month time point minus baseline
A change from baseline to 3-month time points is reported
Adherence
时间窗: Adherence at 3-months (end of intervention)
Count of participants that finished the 3-month intervention
HbA1c
时间窗: Differance between 3 month time point minus baseline
A change from baseline to 3-month time points is reported
次要结局
- LDL, HDL, TG(A change from baseline to 3-month time points is reported)
研究者
Iris Shai
Prof.
The S. Daniel Abraham International Center for Health and Nutrition