Diabetic Retinopathy
Conditions
Keywords
type 2 diabetes mellitus, Diabetic Retinopathy, glucose fluctuation, oxidative stress, Insulin, Oral drugs
Brief summary
Diabetic retinopathy (DR) is an important cause of blindness.
Detailed description
Diabetic retinopathy (DR) is an important cause of blindness, and its development of an irreversible process. DR is not only the overall progress and the level of blood sugar, and blood glucose fluctuations more closely, is the key to a smooth hypoglycemic delay DR progression.Diabetes control and complication trail(DCCT) study shows that even though glycemic control was no significant difference in blood glucose fluctuations ,DR also have a significant difference. In this study, three different glucose-lowering program for: (A) a single oral anti-diabetic drugs, (B) basal insulin and oral anti-diabetic drugs, (C) premixed insulin and oral anti-diabetic drugs for comparison. Focus on the stability and the impact of these three programs hypoglycemic long-term prognosis of the DR, and thus affect the molecular mechanisms of DR-based exploration of glucose fluctuations, to optimize blood glucose solutions, lower blood sugar steady, slow progression of DR ultimate clinical purposes. The multi-center study is to cooperate, enrolled 600 cases of type 2 diabetes, observe the effects of different solutions on blood sugar glucose fluctuations and retinopathy, a total of 5 years of follow-up. This will be the first at home and abroad to compare the incidence of hypoglycemic effect programs on DR large multi-center, randomized, controlled clinical studies, clinical practice will optimize the treatment of type 2 diabetes theoretical and evidence-based medicine.
Interventions
DRUGMetformin
start with metformin，from 500mg bid,if metformin reach the biggest dosage，added gliclazide modified release tablets，afterthat，add acarbose
DRUGLantus
started with insulin glargine 0.2 u/kg subcutaneous injection ，add dosage if glucose dose not reach the target.after that,you can add oral drugs（like oral drug group）
DRUGNovomix30
started with premixed insulin subcutaneous injection(0.4-0.6 u/kg divided into half before breakfast and dinner),and add dosage if glucose dose not reach the target.after that,you can add oral drugs ,as Group Oral Drugs
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. aged 30-65; 2. diagnosed to be type 2 diabetes in accordance with the WHO diagnostic criteria in 1999 . 3. diabetes duration for 5 years or less; 4. the glycosylated hemoglobin (HbA1c) is higher than or equal to7.0% ; 5. body mass index (BMI) 20-35 kg/m2; 6. fluorescein fundus angiography (FFA) showed no diabetic retinopathy; 7. women of childbearing-age have birth control plan for 5 years plan;
Exclusion criteria
1. pregnant or lactating women; 2. diabetes autoantibodies (GAD) antibodies positive; 3. occurred state of diabetic ketoacidosis, diabetes, high permeability, diabetes lactic acidosis within a half years ; 4. aspartate aminotransferase (AST), alanine aminotransferase (ALT) 2.5 times higher than normal ceiling, and/or serum creatinine (Cr) or 133 umol/l (1.5 mg/dl); 5. hemoglobin disease history which can affect determination of HbA1c; 6. have received a coronary angioplasty, coronary artery stent implantation, coronary artery bypass surgery, there was myocardial infarction, unstable angina, and clinical significance of abnormal ecg, cerebrovascular accident, or transient ischemic attack. 7. psychiatric patients; 8. any eye eyesight \< 0.1 patients (WHO blind eye disease: keratitis, need serious cataract surgery, glaucoma, uveitis, high myopia shaft \> 26.5 mm, history of ocular trauma;Other ophthalmology medical history: the central vein occlusion, branch vein occlusion, wet sex senile macular degeneration, etc.; 9. in eye surgery history, history of cataract surgery, and three months; Other serious diseases, the researchers think that don't fit into the patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of diabetic retinopathy | 5years | 5-year incidence rate of diabetic retinopathy（%） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cardiovascular events | 5 years | myocardial infarction, angina,or cardiac insufficiency with other causes |
| renal failure | 5years | use urinary protein excretion rate（%） evaluate clinical course of diabetic nephropathy |
| glucose fluctuation | every one year in 5years | we use continuous glucose monitoring system（CGMS）,made by Medtronic company USA,and assess within-day blood glucose excursions,Daytime blood sugar stability and the stability of postprandial blood glucose,including Standard Deviation Of Blood Glucose（SDBG）in mmol/L, largest amplitude of glycemic excursions(LAGE)in mmol/L, mean amplitude of glycemic excursions(MAGE) in mmol/L,low glycemic index(LBMI),coefficient variation fasting glucose parameters,Mean Of Daily Differences(MODD)in mmol/L. |
| oxidative stress | every one year in 5 years | Glyoxalase 1(GLO-1)in pg/ml,Advanced glycation end products(AGEs）in pg/ml,Soluble Receptor for advanced glycation end products(sRAGE）in pg/ml. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Metabolic indices | every three months in 5 years | Fasting blood glucose（FBG）in mmol/L, postprandial blood glucose（PBG）in mmol/L, glycosylated hemoglobin（GHbA1c）in percentage.total cholesterol（TC), low density lipoprotein(LDL) and high density lipoprotein(HDL)in mmol/L. |
Countries
China
Contacts
Primary ContactChen Yanming, Doctor
Backup ContactZhu Bilian, Master
Outcome results
None listed