The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- heart rate variability（HRV）
研究概览
简要总结
Diabetic cardiac autonomic neuropathy (DCAN) is a common chronic complication that reduces survival in patients with diabetes. Epidemiological surveys have shown that the prevalence of DCAN is 25-75% in people with type 2 diabetes. The onset of DCAN is insidious and easy to be ignored in the early stage. With the progression of the disease, the following clinical symptoms gradually appear, including reduced heart rate variability, exercise intolerance, resting tachycardia, orthostatic hypotension, painless myocardial infarction and even sudden death, which seriously endanger the life and health of type 2 diabetes patients. Existing literature has shown that glucagon-like peptide-1 receptor agonist (GLP-1RA) can improve diabetic peripheral neuropathy and diabetic cognitive dysfunction, but there are few studies on improving diabetic autonomic neuropathy. Insulin resistance is an important risk factor for DCAN. Patients with type 2 diabetes are characterized by insulin resistance, and GLP-1RA is recognized as a drug to improve insulin resistance and control blood sugar in patients with diabetes. In this study, GLP-1RA was used to intervene patients with type 2 diabetes, and the changes in blood sugar control and insulin resistance status of patients were followed up. Special attention was paid to the improvement of autonomic neuropathy in diabetic patients.
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
- Single (Outcomes Assessor)
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 T2DM who meet the diagnostic guidelines
- •The patient signed the relevant informed consent form
- •Being overweight or obese
排除标准
- •<18 years old
- •Pregnant or lactating women
- •Acute and chronic pancreatitis
- •Recent acute complications of diabetes
- •Arrhythmia or taking drugs that affect heart rate
- •Thyroid disease
- •Severe organ dysfunction
- •Denial of informed consen
研究组 & 干预措施
GLP-1RA intervention group
Subcutaneous injection of semaglutide 0.5-1mg （dosage depends on individual body weight）once a week (not off-label use)，lasting 12 weeks
干预措施: Glucagon-like peptide-1 receptor agonist：Semaglutide (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)
- BMI(basline and 12 weeks later)
- FBG(basline and 12 weeks later)
- HOMA-IR(basline and 12 weeks later)
- eGFR(basline and 12 weeks later)
- Urinary trace albumin/urinary creatinine(basline and 12 weeks later)
- HbA1c(basline and 12 weeks later)
- Total cholesterol(basline and 12 weeks later)
- HDL(basline and 12 weeks later)
- LDL(basline and 12 weeks later)
- UA(basline and 12 weeks later)
- creatinine(basline and 12 weeks later)
- triglyceride(basline and 12 weeks later)
- Fins(basline and 12 weeks later)
- Fc-peptide(basline and 12 weeks later)