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

Nanjing Medical University

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Glucagon-like peptide-1 receptor agonist：Semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT06461377

2023-SR-611

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

control

No Intervention group

Description:

In the control group, no other intervention was used except the basic drugs for diabetes treatment

GLP-1RA intervention group

Experimental group

Description:

Subcutaneous injection of semaglutide 0.5-1mg （dosage depends on individual body weight）once a week (not off-label use)，lasting 12 weeks

Treatment:

Drug: Glucagon-like peptide-1 receptor agonist：Semaglutide