Clinical trial

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

Name
2023-SR-611
Description
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.
Trial arms
Trial start
2024-06-07
Estimated PCD
2026-12-31
Trial end
2027-12-31
Status
Not yet recruiting
Phase
Early phase I
Treatment
Glucagon-like peptide-1 receptor agonist:Semaglutide
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
Arms:
GLP-1RA intervention group
Other names:
Semaglutide
Size
50
Primary endpoint
heart rate variability(HRV)
baseline and 12 weeks later
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2024-06-17

1 organization

1 product

2 indications

Indication
Type 2 Diabetes
Indication
Diabetes