Recruiting

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

ClinicalTrials.gov IDNCT07558863

PhasePHASE4

Enrollment60

SponsorThe First Affiliated Hospital with Nanjing Medical University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes, Diabetes With Diabetic Autonomic Neuropathy (Diagnosis)

About this study

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.

Interventions

Drug: GLP-1 Receptor Agonists — GLP-1 receptor agonists are administered as a once-weekly subcutaneous injection for 6 months. Two specific GLP-1RAs are used in this study: semaglutide at 0.5 mg once weekly, or polyethylene glycol loxenatide at 0.2 mg once weekly. Both are approved for the treatment of type 2 diabetes and are used within their approved dosing guidelines.

Primary outcomes

heart rate variability（HRV） (baseline and 12 weeks later])

Eligibility information

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

Study locations

the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.