Diabetic retinopathy (DR) is an important cause of blindness.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
600
start with metformin,from 500mg bid,if metformin reach the biggest dosage,added gliclazide modified release tablets,afterthat,add acarbose
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)
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
the third affiliated hospital of Sun yet-san university
Guangzhou, Guangdong, China
RECRUITINGThe incidence of diabetic retinopathy
5-year incidence rate of diabetic retinopathy(%)
Time frame: 5years
cardiovascular events
myocardial infarction, angina,or cardiac insufficiency with other causes
Time frame: 5 years
renal failure
use urinary protein excretion rate(%) evaluate clinical course of diabetic nephropathy
Time frame: 5years
glucose fluctuation
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.
Time frame: every one year in 5years
oxidative stress
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.
Time frame: every one year in 5 years
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