The Effect of Autonomic Neuropathy Status on the Endpoint Events in Diabetes Patients With Coronary Heart Disease and Sleep Apnea.

Sponsor
Xiangtan Central Hospital
Study ID
NCT07723222
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular Autonomic Neuropathy (CAN)
  • Coronary Heart Disease
  • Diabetes
  • Sleep Apnea Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • The total score of Ewing test (i.e. cardiovascular autonomic reflex test and heart rate variability) was ≥1, which was divided into cardiac autonomic neuropathy group (CAN grou — BEHAVIORAL
    Avoid vigorous exercise the day before and on the day of the test. Avoid strong tea, coffee, and alcohol for at least 2 hours before the test. Conduct the test 2 hours after meals and rest in bed for at least 20 minutes. Each test should be conducted with a 5-minute interval Vagus nerve function test (mainly affecting heart rate) Heart rate response in supine position (30:15 ratio): * Operation: The subject actively stands up from the supine position and records the electrocardiogram. * Calculation: Divide the longest RR interval near the 30th heartbeat after standing by the shortest RR interval near the 15th heartbeat. * Interpretation: Normal ≥ 1.04, critical 1.01-1.03, abnormal ≤ 1.00. Deep breath heart rate response (breathing difference): * Operation: Take deep breaths at a rate of 6 times per minute (5 seconds for each inhalation and exhalation) for 1 minute. * Calculation: The average of the maximum heart rate minus the minimum heart rate per minute. * Interpretation: Normal

Study Details

Background: diabetes combined with cardiac autonomic neuropathy (CAN) can denervate the heart, which may prevent patients with sleep apnea syndrome from bradycardia in the early stage, and directly show an increased risk of tachyarrhythmia and sudden cardiac death. This means that many diabetes patients with sleep apnea syndrome who are at risk of sudden death may be ignored due to the lack of the typical signal of "bradycardia". A study showed 299 events among 165 participants, of which 132 participants (10%) had CAN and experienced 244 cardiovascular events, and 33 participants (25%) had CAN and experienced 55 cardiovascular events (hazard ratio \[HR\] 2.79, 95% CI 1.91). In this trial, the effect of autonomic neuropathy on the end point events of type 2 diabetes patients with coronary heart disease and sleep apnea was investigated. Objective: This study is a prospective, single-center, observational study to investigate the effect of autonomic neuropathy status on the endpoint events in patients with coronary heart disease, diabetes, and sleep apnea syndrome. Methods : Diagnosed coronary heart disease (coronary angiography showed coronary artery stenosis ≥ 50%), diabetes (fasting blood glucose ≥ 7 mmol/L, blood glucose ≥ 11.1 mmol/L 2 hours after OGTT meal, HbA1c ≥ 6.5%, or random blood glucose ≥ 11.1 mmol/L), sleep apnea syndrome (≥ 5 apnea or hypoventilation events per hour during sleep (AHI ≥ 5 times/hour), and associated symptoms or health risks. ）The patient. The Ewing test was divided into two groups: the group without concomitant cardiac autonomic neuropathy and the group with cardiac autonomic neuropathy. The primary endpoint includes all-cause mortality events during follow-up, and the secondary endpoint includes the occurrence of cardiovascular events. This study will explore the influence of autonomic neuropathy on the endpoint events of patients with diabetes, coronary heart disease and sleep apnea. Keywords: coronary heart disease, diabetes, sleep apnea syndrome, cardiovascular autonomic neuropathy, results

Key Dates

First listed
Jul 23, 2026
Start date
Aug 1, 2026
Status verified
Jul 2026
Primary completion
Aug 1, 2028
Completion
Aug 1, 2031

Study Design

Enrollment
326 participants (estimated)

Arms

  • Arm: CAN group
    Cardiovascular autonomic neuropathy group
  • Arm: Non-CAN group
    Non-Cardiovascular autonomic neuropathy group

Primary Outcome Measure

All-cause death event [ Time Frame: Follow up endpoint events after 3 years of enrollment. ]

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