The Benefits of Intensive Glycemic Control in Elderly Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately.
研究概览
简要总结
Aims/hypothesis:
Populations worldwide are aging and type 2 diabetes is common in individuals aged >80 years. The important issue that needs to be considered is whether tight glycemic control is benefits for elderly patients with type 2 diabetes. The benefits of intensive glucose control remain uncertain for the heterogeneous population of older diabetic patients due to a lack of clinical trial data evaluating the benefits of long-term intensive glucose control in older patients. This study is designed to provide reliable evidence on the balance of benefits and risks conferred by intensive glucose control in elderly patients with type 2 diabetes Methods: This is a prospective, randomized, open-labeled, controlled design to assess the benefits of treating elderly patients with type 2 diabetes. The study will include 208 elderly patients with type 2 diabetes and follow-up for 5 years. Eligible patients are randomized to receive intensive (A1C <7.0%) or conservative (A1C around 8.0%) glycemic control. The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately. The secondary outcomes are death from any cause, death from cardiovascular causes, total coronary events, total cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events, and hospitalization for 24 hours or more.
Expected results: This study is designed to provide reliable evidence on the balance of benefits and risks conferred by intensive and conservative glucose control in elderly patients with type 2 diabetes. Once completed, this trial will clearly influence the management of elderly patients with type 2 diabetes, regardless of the results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged ≥80 years at time of randomization.There is no upper age limit.
- •Be able to walk by themselves
- •They had their first diagnosis of type 2 diabetes mellitus at age 30 years or older.
排除标准
- •Known advanced diabetic complications (such as proliferative retinopathy, chronic kidney disease stage IV or above).
- •Overt clinical congestive heart failure (CHF) requiring treatment with a diuretic or ACE inhibitor.
- •Previous documented cerebral or subarachnoid haemorrhage in the last 6 months
- •Condition expected to severely limit survival
- •Clinical diagnosis of dementia
- •Resident in a nursing home
研究组 & 干预措施
1
Fasting plasma glucose (mg/dL) 90 to 130 Glycated hemoglobin (%) 6.0 to 7.0
干预措施: Intensive glycemic control (Drug)
2
Fasting plasma glucose (mg/dL) 90 to 180 Glycated hemoglobin (%) 7.0 to 9.0
干预措施: Conservative glycemic control (Drug)
结局指标
主要结局
The primary study outcomes are a composite of macrovascular events and a composite of microvascular events, considered both jointly and separately.
时间窗: Every 6 months and up to 5 years
次要结局
- The secondary outcomes are death from any cause, disability from any cause, total coronary events, total cerebrovascular events, heart failure, peripheral vascular events, all cardiovascular events, and hospitalization for 24 hours or more.(Every 6 months and upto 5 years)