Evaluation of the Effect of Sodium-Glucose Cotransporter-2 (SGLT2) Inhibitors on Diabetic Retinopathy in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Evaluation of the study biomarkers, IL-6, and VEGF
研究概览
简要总结
A prospective, randomized, open-label, controlled clinical trial will be conducted at the endocrinology department - Ain Shams University (ASU) hospital. Sixty patients will be enrolled into the study. 30 of which will receive dapagliflozin 10mg tab once daily and the other thirty will receive their standard antidiabetic therapy for 12 weeks.
详细描述
All type 2 diabetes mellitus patients presenting to the endocrinology department, ASU Hospitals, who were diagnosed with mild to moderate non-proliferative diabetic retinopathy will be assessed for eligibility.
Eligible patients will be randomly assigned to one of the following 2 arms:
- Group 1 (Control group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic for 12 weeks.
- Group 2 (Test group) (n= 30): type 2 diabetes mellitus patients who will receive their oral antidiabetic along with dapagliflozin at a dose of 10 mg daily for 12 weeks.
A total of four visits one for baseline evaluation and one for end of study evaluation and two intermediate visits, the following will be performed in the visits:
- Clinical Evaluation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male aged between 40 and 70 years old.
- •Glomerular filtration rates > 60 mL/min.
- •Normal aspartate and alanine transaminase levels.
- •Controlled systolic and diastolic blood pressures
排除标准
- •Patients using insulin or more than one oral anti-diabetic drug.
- •Patients who have HbA1c level ≥10% (86 mmol/mol) or a fasting plasma glucose level >240 mg/dl.
- •Patients with a history of cardiovascular events within six months before enrolment.
- •Patients suffering from cataract or glaucoma.
- •Patients with volume depletion clinical signs.
- •Body mass index (BMI) >40 kg/m2
- •Infectious or inflammatory diseases.
- •Neoplasm, or hematological disorders.
- •Pregnant or breast-feeding patients.
- •Active participation in another clinical study.
研究组 & 干预措施
Test group
(n=30): type 2 diabetes mellitus patients who will receive an oral antidiabetic along with dapagliflozin at a dose of 10 mg daily for 12 weeks.
干预措施: Dapagliflozin 10mg Tab plus another oral hypoglycemic agent (Drug)
Control group
(n=30): type 2 diabetes mellitus patients who will receive two oral antidiabetic agents for 12 weeks
干预措施: Two oral hypoglycemic agents other than dapagliflozin (Drug)
结局指标
主要结局
Evaluation of the study biomarkers, IL-6, and VEGF
时间窗: 12 weeks
Interleukin-6 (IL-6)//inflammatory biomarker Vascular endothelial growth factor (VEGF)//angiogenic biomarker
Severity of retinopathy
时间窗: 12 weeks
evaluate the change of stage of disease according to diabetic retinopathy severity scale,, Which is the International Clinical Disease Severity Scale (ICDSS) for DR. This scale classified the severity of disease into five stages ( No apparent retinopathy, Mild Non proliferative Diabetic retinopathy (NPDR) ,Mod NPDR, Severe NPDR ,Proliferative Diabetic Retinopathy) depend on eye examination. higher scores mean worse outcome.
次要结局
- Occurrence of adverse events((1-90)days)
研究者
Nidae Alaa
Principal Investigator
Ain Shams University