Clinical trial

The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy

Recruiting now · Phase 4 · 1 countries · Registry ID NCT06461377

Recruiting nowPhase 4Interventional

What this study is about

Diabetic cardiac autonomic neuropathy (DCAN) is a common chronic complication that reduces survival in patients with diabetes. Epidemiological surveys have shown that the prevalence of DCAN is 25-75% in people with type 2 diabetes. The onset of DCAN is insidious and easy to be ignored in the early stage. With the progression of the disease, the following clinical symptoms gradually appear, including reduced heart rate variability, exercise intolerance, resting tachycardia, orthostatic hypotension, painless myocardial infarction and even sudden death, which seriously endanger the life and health of type 2 diabetes patients. Existing literature has shown that glucagon-like peptide-1 receptor agonist (GLP-1RA) can improve diabetic peripheral neuropathy and diabetic cognitive dysfunction, but there are few studies on improving diabetic autonomic neuropathy. Insulin resistance is an important risk factor for DCAN. Patients with type 2 diabetes are characterized by insulin resistance, and GLP-1RA is recognized as a drug to improve insulin resistance and control blood sugar in patients with diabetes. In this study, GLP-1RA was used to intervene patients with type 2 diabetes, and the changes in blood sugar control and insulin resistance status of patients were followed up. Special attention was paid to the improvement of autonomic neuropathy in diabetic patients.

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: 1. Patients aged 18-70 years 2. Patients with T2DM who meet the diagnostic guidelines 3. The patient signed the relevant informed consent form 4. Being overweight or obese Exclusion Criteria: 1. \<18 years old 2. Pregnant or lactating women 3. Acute and chronic pancreatitis 4. Recent acute complications of diabetes 5. Arrhythmia or taking drugs that affect heart rate 6. Thyroid disease 7. Severe organ dysfunction 8. Denial of informed consen

Treatments and study arms

Glucagon-like peptide-1 receptor agonist：Semaglutide

Drug

The GLP-1RA intervention group was given subcutaneous injection of GLP-1RA for 3 months, while the control group was not given GLP-1RA intervention

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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