A Study on the Effect of GLP-1 Receptor Agonist (GLP-1RA) Intervention on Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- heart rate variability（HRV）
研究概览
简要总结
This study aims to investigate whether a class of diabetes medications called GLP-1 receptor agonists (GLP-1RA), specifically semaglutide or polyethylene glycol loxenatide, can improve heart-related nerve damage in people with type 2 diabetes. This heart-related nerve damage is known as diabetic cardiac autonomic neuropathy (DCAN), which can cause problems such as fast resting heart rate, low blood pressure upon standing, and in severe cases, heart attack or sudden death.
In this study, 60 adults with type 2 diabetes (ages 18-80) will be randomly divided into two groups. One group will receive standard diabetes care only, while the other group will receive standard care plus a once-weekly injection of either semaglutide or polyethylene glycol loxenatide for 6 months. Participants will undergo tests before and after the treatment period, including blood tests and non-invasive heart function tests (24-hour heart rate variability monitoring and cardiac autonomic reflex tests).
The main goal is to see whether GLP-1RA treatment improves heart rate variability, a key sign of heart nerve function. The study also looks at changes in body weight, blood sugar control, and insulin resistance. This research may help determine whether GLP-1RA medications can protect against or improve diabetic heart nerve damage, beyond their known benefits for blood sugar control.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70 years
- •Patients with type 2 diabetes mellitus (T2DM) who meet the diagnostic guidelines
- •Patient has signed the relevant informed consent form
- •Being overweight or obese (BMI ≥ 24 kg/m²)
排除标准
- •Age < 18 years
- •Pregnant or lactating women
- •Acute or chronic pancreatitis
- •Recent acute complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state)
- •Arrhythmia or taking medications that affect heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, antiarrhythmic drugs)
- •Thyroid disease
- •Severe organ dysfunction (e.g., heart, liver, kidney failure)
- •Denial of informed consent
研究组 & 干预措施
Control Group
Participants receive standard diabetes care (routine glucose-lowering treatment) without GLP-1 receptor agonist (GLP-1RA) intervention.
GLP-1 Receptor Agonist (GLP-1RA) Group
Participants receive standard diabetes care plus a once-weekly subcutaneous injection of a GLP-1 receptor agonist (either semaglutide or polyethylene glycol loxenatide) for 6 months. Semaglutide is administered at 0.5 mg once weekly; polyethylene glycol loxenatide is administered at 0.2 mg once weekly. Both are used within approved labeling for type 2 diabetes.
干预措施: GLP-1 Receptor Agonists (Drug)
结局指标
主要结局
heart rate variability（HRV）
时间窗: baseline and 12 weeks later]
All participants were given ambulatory electrocardiogram.The time domain analysis and frequency domain analysis of heart rate variability are included in the holter ECG report.
次要结局
- E/I difference(basline and 12 weeks later)
- 30/15 ratio(basline and 12 weeks later)
- Valsalva action(basline and 12 weeks later)
- the difference between lying and Orthostatic blood pressure(basline and 12 weeks later)
- grip strength tests(basline and 12 weeks later)