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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral drugs | Experimental | oral anti-diabetic drugs only.metformin,start from 500mg bid,if blood glucose dose not reach the standard，added to 500mg tid→1000mg bid.if metformin reach the biggest dosage，added gliclazide modified release tablets，from 30mg qd,if blood glucose dose not reach the standard,add dosage 30mg qd→60 mg qd→90mg qd→120mg qd(max).if still not reach the target，add acarbose 50mg tid |
|
| lantus | Experimental | basal insulin combine with oral drugs,started with insulin glargine 0.2 u/kg subcutaneous injection at 10pm（at 8am if patients are night workers）,add dosage if glucose dose not reach the target.after that,you can add oral drugs ,as Group Oral Drugs. |
|
| Novomix30 | Experimental | premixed insulin combine with oral drugs,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 . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | start with metformin，from 500mg bid,if metformin reach the biggest dosage，added gliclazide modified release tablets，afterthat，add acarbose |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of diabetic retinopathy | 5-year incidence rate of diabetic retinopathy（%） | 5years |
| Measure | Description | Time Frame |
|---|---|---|
| cardiovascular events | myocardial infarction, angina,or cardiac insufficiency with other causes | 5 years |
| renal failure | use urinary protein excretion rate（%） evaluate clinical course of diabetic nephropathy |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic indices | 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. | every three months in 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chen Yanming, Doctor | Contact | +8618922102818 | 1211587508@qq.com | |
| Zhu Bilian, Master | Contact | +8613580364394 | bilianzhu@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Mu panwei, Doctor | Employ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the third affiliated hospital of Sun yet-san university | Recruiting | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17896294 | Result | Klein BE. Overview of epidemiologic studies of diabetic retinopathy. Ophthalmic Epidemiol. 2007 Jul-Aug;14(4):179-83. doi: 10.1080/09286580701396720. | |
| 15078674 | Result | Kempen JH, O'Colmain BJ, Leske MC, Haffner SM, Klein R, Moss SE, Taylor HR, Hamman RF; Eye Diseases Prevalence Research Group. The prevalence of diabetic retinopathy among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):552-63. doi: 10.1001/archopht.122.4.552. |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D020909 | Acarbose |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D014312 |
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|
| Lantus | Drug | 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） |
|
|
| Novomix30 | Drug | 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 |
|
|
| 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. | 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. | every one year in 5 years |
| 11522720 | Result | Fischbacher CM, Bhopal R, Unwin N, Walker M, White M, Alberti KG. Maternal transmission of type 2 diabetes varies by ethnic group: cross-sectional survey of Europeans and South Asians. Diabetes Care. 2001 Sep;24(9):1685-6. doi: 10.2337/diacare.24.9.1685-a. No abstract available. |
| 10857967 | Result | Muggeo M, Zoppini G, Bonora E, Brun E, Bonadonna RC, Moghetti P, Verlato G. Fasting plasma glucose variability predicts 10-year survival of type 2 diabetic patients: the Verona Diabetes Study. Diabetes Care. 2000 Jan;23(1):45-50. doi: 10.2337/diacare.23.1.45. |
| 19064853 | Result | White NH, Sun W, Cleary PA, Danis RP, Davis MD, Hainsworth DP, Hubbard LD, Lachin JM, Nathan DM. Prolonged effect of intensive therapy on the risk of retinopathy complications in patients with type 1 diabetes mellitus: 10 years after the Diabetes Control and Complications Trial. Arch Ophthalmol. 2008 Dec;126(12):1707-15. doi: 10.1001/archopht.126.12.1707. |
| 21813293 | Result | Lin SD, Wang JS, Hsu SR, Sheu WH, Tu ST, Lee IT, Su SL, Lin SY, Wang SY, Hsieh MC. The beneficial effect of alpha-glucosidase inhibitor on glucose variability compared with sulfonylurea in Taiwanese type 2 diabetic patients inadequately controlled with metformin: preliminary data. J Diabetes Complications. 2011 Sep-Oct;25(5):332-8. doi: 10.1016/j.jdiacomp.2011.06.004. Epub 2011 Aug 2. |
| 20082624 | Result | Bao YQ, Zhou J, Zhou M, Cheng YJ, Lu W, Pan XP, Tang JL, Lu HJ, Jia WP. Glipizide controlled-release tablets, with or without acarbose, improve glycaemic variability in newly diagnosed Type 2 diabetes. Clin Exp Pharmacol Physiol. 2010 May;37(5-6):564-8. doi: 10.1111/j.1440-1681.2010.05361.x. Epub 2010 Jan 17. |
| 16681561 | Result | Bott S, Tusek C, Jacobsen LV, Endahl L, Draeger E, Kapitza C, Heise T. Insulin detemir under steady-state conditions: no accumulation and constant metabolic effect over time with twice daily administration in subjects with Type 1 diabetes. Diabet Med. 2006 May;23(5):522-8. doi: 10.1111/j.1464-5491.2006.01839.x. |
| 20970870 | Result | Mu P, Lu H, Zhang G, Chen Y, Fu J, Wang M, Shu J, Zeng L. Comparison of fasting capillary glucose variability between insulin glargine and NPH. Diabetes Res Clin Pract. 2011 Jan;91(1):e4-7. doi: 10.1016/j.diabres.2010.09.026. |
| 32977802 | Derived | Li S, Tang X, Luo Y, Wu B, Huang Z, Li Z, Peng L, Ling Y, Zhu J, Zhong J, Liu J, Chen Y. Impact of long-term glucose variability on coronary atherosclerosis progression in patients with type 2 diabetes: a 2.3 year follow-up study. Cardiovasc Diabetol. 2020 Sep 25;19(1):146. doi: 10.1186/s12933-020-01126-0. |
| 30992008 | Derived | Tang X, Zhong J, Zhang H, Luo Y, Liu X, Peng L, Zhang Y, Qian X, Jiang B, Liu J, Li S, Chen Y. Visit-to-visit fasting plasma glucose variability is an important risk factor for long-term changes in left cardiac structure and function in patients with type 2 diabetes. Cardiovasc Diabetol. 2019 Apr 16;18(1):50. doi: 10.1186/s12933-019-0854-9. |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006946 | Hyperinsulinism |
| Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |