NCT07558863RecruitingPhase 4
Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes
A Study on the Effect of GLP-1 Receptor Agonist (GLP-1RA) Intervention on Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 30 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 30 Mar 2028
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07558863
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 1 Apr 2026 to the primary completion date, 30 Mar 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Recent acute complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state)
- Thyroid disease
- Severe organ dysfunction (e.g., heart, liver, kidney failure)
Lab values
- Arrhythmia or taking medications that affect heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, antiarrhythmic drugs)
Age
- Age \< 18 years
Other
- Pregnant or lactating women
- Acute or chronic pancreatitis
- Denial of informed consent
Who the study is looking for
- 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)
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.