Clinical trial NCT02587741: Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens
Official title: Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens: a Multicentre Randomized Parallel-group Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Diabetic Retinopathy
Keywords: type 2 diabetes mellitus
Diabetic Retinopathy
glucose fluctuation
oxidative stress
Insulin
Oral drugs
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 600
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The incidence of diabetic retinopathy
timeFrame: 5years
Secondary outcomes:
measure: cardiovascular events
timeFrame: 5 years
measure: renal failure
timeFrame: 5years
measure: glucose fluctuation
timeFrame: every one year in 5years
measure: oxidative stress
timeFrame: every one year in 5 years
Other outcomes:
measure: Metabolic indices
timeFrame: every three months in 5 years
Locations:
city: Guangzhou
country: China
facility: the third affiliated hospital of Sun yet-san university
state: Guangdong
Study officials:
affiliation: Employ
name: Mu panwei, Doctor
role: PRINCIPAL_INVESTIGATOR
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