Comparison of Diabetes Retinopathy Among Type 2 Diabetic Patients Treated With Different Regimens

  • STATUS
    Recruiting
  • End date
    Jul 21, 2025
  • participants needed
    600
  • sponsor
    Third Affiliated Hospital, Sun Yat-Sen University
Updated on 21 January 2021
diabetes
angiography
insulin
body mass index
type 2 diabetes mellitus
metformin
hemoglobin a1c
glycosylated hemoglobin
blindness
retinopathy
diabetic retinopathy

Summary

Diabetic retinopathy (DR) is an important cause of blindness.

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.

Details
Condition Diabetic Retinopathy, Diabetic Retinopathy, Diabetic Macular Edema, Diabetic Macular Edema
Treatment Metformin, Lantus, Novomix30
Clinical Study IdentifierNCT02587741
SponsorThird Affiliated Hospital, Sun Yat-Sen University
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

aged 30-65
# 2\. diagnosed to be type 2 diabetes in accordance with the WHO diagnostic
criteria in 1999
\. diabetes duration for 5 years or less
\. the glycosylated hemoglobin (HbA1c) is higher than or equal to7.0%
\. body mass index (BMI) 20-35 kg/m2
\. fluorescein fundus angiography (FFA) showed no diabetic retinopathy
\. women of childbearing-age have birth control plan for 5 years plan

Exclusion Criteria

pregnant or lactating women
diabetes autoantibodies (GAD) antibodies positive
occurred state of diabetic ketoacidosis, diabetes, high permeability, diabetes lactic acidosis within a half years
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)
hemoglobin disease history which can affect determination of HbA1c
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
psychiatric patients
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
in eye surgery history, history of cataract surgery, and three months; Other serious diseases, the researchers think that don't fit into the patients
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