Effect of a Low-Carbohydrate Mediterranean Diet or Low-Fat Diet in Newly-Diagnosed Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The major environmental factors that increase the risk of type 2 diabetes, presumably in the setting of genetic risk, are overnutrition and a sedentary lifestyle, with consequent overweight and obesity. The high rate of weight regain has limited the role of lifestyle interventions as an effective means of controlling glycemia long term. The aims of the present study were: 1) To compare the effectiveness and safety of two nutritional protocols - namely low-carbohydrate Mediterranean diet or low-fat diet - in newly-diagnosed, drug-naive overweight patients with type 2 diabetes mellitus. The primary aim of the study was the effect on hemoglobin A1c levels; secondary aims were time to introduction of the first hypoglycemic agent, prevalence of the metabolic syndrome, percentage of patients meeting ADA goals for risk factors (HbA1c, blood pressure, LDL-cholesterol, percentage of patients with HbA1c < 7%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus (ADA criteria)
- •BMI (body mass index) > 25 kg/M2
- •Hemoglobin A1c (HbA1c) < 11%; Blood pressure < 160 (systolic) and 100 (diastolic) mm Hg
- •Triglyceride levels < 500 mg/dl.
排除标准
- •Pregnancy or breast-feeding
- •Previous use of insulin or oral antidiabetic drugs
- •Investigational drug within the previous 3 months
- •Use of agents affecting glycemic control (systemic steroids and weight loss drugs)
- •Patients with history of alcohol or illicit drug abuse
- •Patients with liver enzymes higher than three times the upper limit of normal
- •Serum creatinine > 1.4 mg/dl.
结局指标
主要结局
Hemoglobin A1c
时间窗: Every sixth month
次要结局
- Time to introduction of an oral hypoglycemic agent(Every year)