Clinical trial

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

Recruiting now · Phase 4 · 1 countries · Registry ID NCT07558863

Recruiting nowPhase 4Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

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

Treatments and study arms

GLP-1 Receptor Agonists

Drug

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]

All participants were given ambulatory electrocardiogram.The time domain analysis and frequency domain analysis of heart rate variability are included in the holter ECG report.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

the First Affiliated Hospital of Nanjing Medical University🇨🇳 Nanjing, Jiangsu, China

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jianbo Li, Principal InvestigatorContact

Email · Call 13115008178