Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes
Recruiting · NCT07558863 · Interventional (participants receive a specific treatment) · Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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)
Exclusion criteria
- 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
Where it is running
1 location listed.
- the First Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China