Low Glycemic Diet Intervention and Community Diabetic Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficiency of Nutrition Education-based Low Glycemic Diet Intervention on Community Diabetic Patients

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: low glycemic diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes group<br>During the trial period, the participants who are diagnosed of diabetes are instructed to consume low glycemic diet every day | Behavioral: low glycemic diet<br>* nutrition education-based low glycemic diet intervention<br>|
| Experimental: Fatty group<br>During the trial period, the participants who are diagnosed of obesity are instructed to consume low glycemic diet every day | Behavioral: low glycemic diet<br>* nutrition education-based low glycemic diet intervention<br>|
| Experimental: Impaired glucose tolerance group<br>During the trial period, the participants who are diagnosed of impaired glucose tolerance are instructed to consume low glycemic diet every day | Behavioral: low glycemic diet<br>* nutrition education-based low glycemic diet intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated hemoglobin (HbA1c) | 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. | Change from Baseline HbA1c at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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） | 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 | Baseline and 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low glycemic diet, diabetes