Effect of Tight Glycemic Control on Microvascular Complications in Type 2 Diabetes Mellitus: A Randomized Controlled Trial in an Egyptian Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Effect of Tight Glycemic Control on Microvascular Complications (Retinopathy, neuropathy and Nephropathy) in Type 2 Diabetes Mellitus in 80 patients divided into two groups according to their HbA1c
研究概览
简要总结
The goal of this clinical trial is to learn the impact of tight versus less tight glycemic control on microvascular complications among Egyptian adults with uncontrolled T2DM. The main question it aims to answer is:
Does tight glycemic control improve or worsens microvascular complications of diabetes compared to less tight glycemic control?
Participants will:
- Be divided to two groups according to their HbA1c group A tight glycemic control and less tight glycemic control.
- Be followed for 6 months with clinical, laboratory, and fundoscopic evaluations performed at baseline and endpoint.
详细描述
Background: Tight glycemic control is widely promoted in the management of type 2 diabetes mellitus (T2DM) to reduce microvascular complications, yet the extent and speed of HbA1c reduction may paradoxically exacerbate certain outcomes.
Objective
To assess the impact of tight versus less tight glycemic control on microvascular complications among Egyptian adults with uncontrolled T2DM.
Methods: In this randomized controlled trial, 80 patients with poorly controlled T2DM (HbA1c >7.5%) were randomized into two groups: Group A (tight control, HbA1c <7.0%) and Group B (less tight control, HbA1c <7.5%). Participants were followed for 6 months with clinical, laboratory, and fundoscopic evaluations performed at baseline and endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes.
- •Age 18-60years old.
- •Patients diagnosed with Diabetes Mellitus (Type 2) according to American Diabetes Association (ADA) guidelines.
- •Patients willing to participate after signing a written consent to be enrolled in the study after being explained to them in an interview.
- •Diabetic patients with mild and moderate non proliferative diabetic retinopathy
排除标准
- •Patients with age above 60 or below 18 years old.
- •Patients with severe non proliferative diabetic retinopathy up to advanced proliferative diabetic retinopathy.
- •Patients diagnosed with type 1 DM.
- •Patients with malignant tumours.
- •Patients with end stage renal disease and end stage liver disease.
- •Patients with history of myocardial infarction.
- •Patients with recurrent attacks of hypoglycemia and hypoglycemia unawareness.
结局指标
主要结局
Effect of Tight Glycemic Control on Microvascular Complications (Retinopathy, neuropathy and Nephropathy) in Type 2 Diabetes Mellitus in 80 patients divided into two groups according to their HbA1c
时间窗: 18 months
80 patients with poorly controlled T2DM (HbA1c \>7.5%) were randomized into two groups according to their HbA1c: Group A (tight control, HbA1c \<7.0%) and Group B (less tight control, HbA1c \<7.5%). Participants were followed for 6 months with clinical, laboratory and fundoscopic evaluations performed at baseline and endpoint.
次要结局
未报告次要终点
研究者
Ola Mohamed Moustafa Shaheen
Assistant Lecturer of Internal Medicine, Ain Shams University
Ain Shams University