A Practice-Based, Nutrition Intervention in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c
研究概览
简要总结
The purpose of the study is to assess whether, in individuals with type 2 diabetes, a low-fat, vegan diet improves blood glucose control more effectively than a control diet based on current American Diabetes Association (ADA) guidelines. The principal measure is hemoglobin A1c. Cardiovascular risk factors and dietary acceptability are also assessed. The study duration is 20 weeks with a one-year follow-up.
详细描述
Preliminary evidence suggests that low-fat, vegetarian regimens similar to those used to reverse coronary artery blockages may have a significant beneficial effect on type 2 diabetes, as demonstrated by reductions in fasting serum glucose concentrations and medication use. The investigators therefore randomly assigned 99 individuals with type 2 diabetes to either a low-fat, vegan diet or a diet based on current American Diabetes Association guidelines for 22 weeks with a one-year follow-up period. The principal dependent measure is hemoglobin A1c. Cardiovascular risk factors are also being tracked, as is dietary acceptance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 2 Diabetes Mellitus
排除标准
- •- hemoglobin A1c values <6.5% or >10.5% use of insulin for > 5 years tobacco use within the preceding 6 months consumption of more than 2 alcoholic beverages per day current drug abuse pregnancy unstable medical status current use of a low-fat, vegetarian diet.
研究组 & 干预措施
Low-fat, low-Glycemic Index, vegan diet
Low-fat, low-Glycemic Index, vegan diet
干预措施: Low-fat, low-Glycemic Index, vegan diet (Behavioral)
ADA diet
American Diabetes Association diet
干预措施: ADA diet (Behavioral)
结局指标
主要结局
Hemoglobin A1c
时间窗: 20 weeks
次要结局
- Body Weight(20 Weeks)
- Glucose(20 Weeks)
- Comprehensive Metabolic Panel(20 Weeks & one-year follow up)
- Urinary albumin and creatinine(20 Weeks)
- Waist and hip circumference(20 Weeks)
- Dietary Acceptability(20 Weeks)
- Food Acceptability Questionnaire(20 Weeks)
- CESD-R (Center for Epidemiologic Studies Depression Scale: Review and revision)(20 Weeks)
- Eating Inventory(20 Weeks)
- Beck Depression Inventory II (BDI-II)(20 Weeks)
- Blood Pressure(20 Weeks)
- International Physical Activity Questionnaire(20 Weeks)
- Serum cholesterol and triacylglycerol concentrations(20 Weeks)
- 3-day dietary records(20 Weeks)
- Genotyping for Taq1 A and Taq1 B polymorphisms, and APOE (Apolipoprotein E)(20 Weeks)