Clinical trial NCT06461377: The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy
Official title: The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Diabetes With Diabetic Autonomic Neuropathy (Diagnosis)
Keywords: T2DM，DCAN，HRV, CART，insulin resistance
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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

Primary outcomes:
measure: heart rate variability（HRV）
timeFrame: baseline and 12 weeks later
Secondary outcomes:
measure: E/I difference
timeFrame: basline and 12 weeks later
measure: 30/15 ratio
timeFrame: basline and 12 weeks later
measure: Valsalva action
timeFrame: basline and 12 weeks later
measure: the difference between lying and Orthostatic blood pressure
timeFrame: basline and 12 weeks later
measure: grip strength tests
timeFrame: basline and 12 weeks later
measure: BMI
timeFrame: basline and 12 weeks later
measure: FBG
timeFrame: basline and 12 weeks later
measure: Fins
timeFrame: basline and 12 weeks later
measure: Fc-peptide
timeFrame: basline and 12 weeks later
measure: HOMA-IR
timeFrame: basline and 12 weeks later
measure: HbA1c
timeFrame: basline and 12 weeks later
measure: Total cholesterol
timeFrame: basline and 12 weeks later
measure: triglyceride
timeFrame: basline and 12 weeks later
measure: HDL
timeFrame: basline and 12 weeks later
measure: LDL
timeFrame: basline and 12 weeks later
measure: UA
timeFrame: basline and 12 weeks later
measure: creatinine
timeFrame: basline and 12 weeks later
measure: eGFR
timeFrame: basline and 12 weeks later
measure: Urinary trace albumin/urinary creatinine
timeFrame: basline and 12 weeks later
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: 江苏
Study officials:
affiliation: First Affiliated Hospital，Nanjing Medical University，China
name: jianbo Li, MD/PhD
role: PRINCIPAL_INVESTIGATOR
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