Low Glycemic Diet Intervention and Community Diabetic Patients
- Conditions
- Diabetes
- Interventions
- Behavioral: low glycemic diet
- Registration Number
- NCT02575937
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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）
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Impaired glucose tolerance group low glycemic diet During the trial period, the participants who are diagnosed of impaired glucose tolerance are instructed to consume low glycemic diet every day Diabetes group low glycemic diet During the trial period, the participants who are diagnosed of diabetes are instructed to consume low glycemic diet every day Fatty group low glycemic diet During the trial period, the participants who are diagnosed of obesity are instructed to consume low glycemic diet every day
- Primary Outcome Measures
Name Time Method Change in Glycosylated hemoglobin (HbA1c) 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.
- Secondary Outcome Measures
Name Time Method 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 Method of food frequency questionnaire（FFQ）can be used to monitor the individual over the specified period of time the intake frequencies of certain foods or consumption, so as to determine whether intervention affect their eating habits
Weight Baseline and 6, 12 months Body Mass Index (BMI) Baseline and 6, 12 months
Trial Locations
- Locations (1)
Guangdong Provincial Key Laboratory of Food, Nutrition and Health, Department of Nutrition, School of Public Health, Sun Yat-Sen University (Northern Campus)
🇨🇳Guangzhou, Guangdong, China