Actively Recruiting

Phase 4
Age: 18Years - 70Years
All Genders
NCT07558863

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

Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-04-30

60

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18-70 years
  • Diagnosed with type 2 diabetes mellitus according to diagnostic guidelines
  • Signed the informed consent form
  • Overweight or obese with a body mass index (BMI) of 24 kg/m² or higher
Not Eligible

You will not qualify if you...

  • Younger than 18 years
  • Pregnant or breastfeeding women
  • Acute or chronic pancreatitis
  • Recent acute diabetic complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state
  • Arrhythmia or use of medications affecting heart rate (beta-blockers, non-dihydropyridine calcium channel blockers, antiarrhythmic drugs)
  • Thyroid disease
  • Severe organ dysfunction including heart, liver, or kidney failure
  • Declined to provide informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210029

Actively Recruiting

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Research Team

J

jianbo Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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