Diabetes With Diabetic Autonomic Neuropathy (Diagnosis), Type 2 Diabetes
Conditions
Keywords
T2DM, DCAN, HRV, CART
Brief summary
This study aims to investigate whether a class of diabetes medications called GLP-1 receptor agonists (GLP-1RA), specifically semaglutide or polyethylene glycol loxenatide, can improve heart-related nerve damage in people with type 2 diabetes. This heart-related nerve damage is known as diabetic cardiac autonomic neuropathy (DCAN), which can cause problems such as fast resting heart rate, low blood pressure upon standing, and in severe cases, heart attack or sudden death. In this study, 60 adults with type 2 diabetes (ages 18-80) will be randomly divided into two groups. One group will receive standard diabetes care only, while the other group will receive standard care plus a once-weekly injection of either semaglutide or polyethylene glycol loxenatide for 6 months. Participants will undergo tests before and after the treatment period, including blood tests and non-invasive heart function tests (24-hour heart rate variability monitoring and cardiac autonomic reflex tests). The main goal is to see whether GLP-1RA treatment improves heart rate variability, a key sign of heart nerve function. The study also looks at changes in body weight, blood sugar control, and insulin resistance. This research may help determine whether GLP-1RA medications can protect against or improve diabetic heart nerve damage, beyond their known benefits for blood sugar control.
Interventions
GLP-1 receptor agonists are administered as a once-weekly subcutaneous injection for 6 months. Two specific GLP-1RAs are used in this study: semaglutide at 0.5 mg once weekly, or polyethylene glycol loxenatide at 0.2 mg once weekly. Both are approved for the treatment of type 2 diabetes and are used within their approved dosing guidelines.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18-70 years * Patients with type 2 diabetes mellitus (T2DM) who meet the diagnostic guidelines * Patient has signed the relevant informed consent form * Being overweight or obese (BMI ≥ 24 kg/m²)
Exclusion criteria
* Age \< 18 years * Pregnant or lactating women * Acute or chronic pancreatitis * Recent acute complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) * Arrhythmia or taking medications that affect heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, antiarrhythmic drugs) * Thyroid disease * Severe organ dysfunction (e.g., heart, liver, kidney failure) * Denial of informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| E/I difference | basline and 12 weeks later | Take an average of 6 deep breaths per minute, record the difference between the maximum heart rate and the minimum heart rate during deep breathing |
| 30/15 ratio | basline and 12 weeks later | The heart rate in lying position was measured, and the R-R interval in more than 30 beats was measured after standing, and the ratio between the longest R-R interval in the 25-35 beats and the shortest R-R interval in the 10-15 beats after standing was calculated |
| Valsalva action | basline and 12 weeks later | After deep inhalation, hold your breath as much as possible, and then blow air into the modified sphygmomanometer to keep the pressure of the sphygmomanometer at 40mmHg, continue for 10-15s, and then relax for 1 minute, a total of 3 minutes. At the same time, ECG was recorded to record the ratio of maximum heart rate to minimum heart rate |
| the difference between lying and Orthostatic blood pressure | basline and 12 weeks later | Blood pressure was measured in the supine position. The patient was asked to stand immediately, and blood pressure was measured at the first and fifth minutes |
| grip strength tests | basline and 12 weeks later | First, the basic blood pressure and the maximum grip strength were measured, and the blood pressure was measured after 5 minutes of continuous hard clenching with the grip apparatus (the force used was 30% of the maximum grip strength measured), and the blood pressure difference was calculated |
Countries
China
Contacts
CONTACTjianbo Li
Outcome results
None listed