Diabetes
Conditions
Keywords
low glycemic diet, diabetes
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.
Interventions
BEHAVIORALlow glycemic diet
nutrition education-based low glycemic diet intervention
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Weight | 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 |
| HDL level | Baseline and 6, 12 months | — |
Countries
China
Contacts
Primary ContactMin Xia, PhD
Backup ContactDi Li, Postgraduate
Outcome results
None listed