Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes (GLP-1-CAN)

Nanjing Medical University

Status and phase: Enrolling; Phase 4

Conditions: Diabetes With Diabetic Autonomic Neuropathy (Diagnosis); Type 2 Diabetes

Treatments: Drug: GLP-1 Receptor Agonists

Study type: Interventional

Funder types: Other

Identifiers

NCT07558863

2026-SR-026

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control Group

No Intervention group

Description:

Participants receive standard diabetes care (routine glucose-lowering treatment) without GLP-1 receptor agonist (GLP-1RA) intervention.

GLP-1 Receptor Agonist (GLP-1RA) Group

Experimental group

Description:

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.

Treatment:

Drug: GLP-1 Receptor Agonists