Community Trial to Assess the Effect of Nutritional Intervention Models on Medical Outcomes Among Obese Type 2 Diabetic Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Triglyceride level, glycated hemoglobin level, fasting plasma glucose
研究概览
简要总结
Obese patients with type 2 diabetes often fail to loose weight and thus do not succeed in improving their sugar and lipid profiles and remain at high risk for diabetes complications
The study enrolled 259 obese diabetic patients attending HMO clinics in central Israel. Over a 6 month period the participants met with a dietitian every fortnight and attended group lectures every 2 months.
The objective of this intervention was to compare three dietary intervention along with close monitoring of the patients by dietitians, regarding blood lipid and sugar balance as well as weight loss. The three diets are the American Diabetes Association (ADA) diet from 2003; a diet containing low glycemic index carbohydrate otherwise similar to the ADA diet; and a low glycemic index diet with more fat than the other 2 diets with high proportion of mono-unsaturated fatty acids.
Patients were individually randomized to receive one of the three diets. Among the measures obtained every 3 months for the first year and every 6 months thereafter are weight, fasting insulin and glucose, glycosylated hemoglobin, blood and urine chemistry profiles and lipid profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-65years
- •DM2 diagnosed within 1-10 years
- •Body mass index (BMI) 27-34 kg/m²
- •Last HbA1c measurement 7%-10%
- •Last plasma triglyceride (TG) levels 160-400 mg/dl
- •Last serum creatinine less than 1.4 mg/dl
- •No change in diabetes medication for at least three months before entering the study
排除标准
- •Proliferative diabetic retinopathy
- •Current insulin treatment
- •Active oncologic or psychiatric disease
- •Uncontrolled hypothyroidism or hyperthyroidism
结局指标
主要结局
Triglyceride level, glycated hemoglobin level, fasting plasma glucose
时间窗: baseline and every 3 months during year 1, every 6 months therafter
次要结局
- Weight, BMI, waist hip circumference, insulin resistance using HOMA (fasting glucose to fasting insulin ration), HDL-Cholesterol level.(baseline, every 3 months in year 1, every 6 months therafter)