The Efficiency of Nutrition Education-based Low Glycemic Diet Intervention on Community Diabetic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in Glycosylated hemoglobin (HbA1c)
研究概览
简要总结
The purpose of this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients.
Design: Randomized clinical trial.
Main measures: HbA1c,fasting blood glucose(FBG),2 hours postprandial blood glucose（2hPG）
详细描述
Low glycemic diet can help to control Blood glucose levels，this study is to investigate the efficiency of nutrition education-based low glycemic diet intervention on community diabetic patients,and to improve health outcomes of patients with type 2 diabetes mellitus (T2DM) by influencing disease self-management through lifestyle modification and diet controlling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •subject has a fasting blood glucose between 6.1 and 6.9mmol/L or diagnosed of type 2 diabetes
- •glycosylated hemoglobin(A1C) between 6 and 11%.
- •subject's age≥18 years.
排除标准
- •subject has kidney disease (defined as creatinine>1.3 mg/dl)
- •active liver or gallbladder disease
- •significant heart disease
- •a history of severe hypoglycemia, or use of weight loss medications.
- •subject that is pregnant.
研究组 & 干预措施
Diabetes group
During the trial period, the participants who are diagnosed of diabetes are instructed to consume low glycemic diet every day
干预措施: low glycemic diet (Behavioral)
Fatty group
During the trial period, the participants who are diagnosed of obesity are instructed to consume low glycemic diet every day
干预措施: low glycemic diet (Behavioral)
Impaired glucose tolerance group
During the trial period, the participants who are diagnosed of impaired glucose tolerance are instructed to consume low glycemic diet every day
干预措施: low glycemic diet (Behavioral)
结局指标
主要结局
Change in Glycosylated hemoglobin (HbA1c)
时间窗: Change from Baseline HbA1c at 12 months
Because glycosylated hemoglobin is not affected by plasma glucose fluctuation and can reflect the average blood glucose concentration over the past six to eight weeks.We take a blood sample to check participants' glycosylated hemoglobin concentration at baseline and 12 months respectively.Comparing the change of glycosylated hemoglobin levels, to investigate the effect of the our intervention method.
次要结局
- Weight(Baseline and 6, 12 months)
- Body Mass Index (BMI)(Baseline and 6, 12 months)
- Fasting blood-glucose(Baseline and 6, 12 months)
- Total cholesterol level(Baseline and 6, 12 months)
- HDL level(Baseline and 6, 12 months)
- LDL level(Baseline and 6, 12 months)
- Triglycerides(Baseline and 6, 12 months)
- Food Frequency Questionnaire（FFQ）(Baseline and 6, 12 months)
研究者
Di Li
Doctor of Medicine
Sun Yat-sen University