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

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06461377
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jun 13, 2024
Status verified
Jun 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: control
    In the control group, no other intervention was used except the basic drugs for diabetes treatment
  • Experimental: GLP-1RA intervention group
    Subcutaneous injection of semaglutide 0.5-1mg （dosage depends on individual body weight）once a week (not off-label use)，lasting 12 weeks

Primary Outcome Measure

heart rate variability（HRV） [ Time Frame: baseline and 12 weeks later ]

Central Contacts

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