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

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

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Key information

Conditions

Coronary Heart Disease Apnea Cardiovascular Autonomic Neuropathy (CAN) Cardiovascular Diseases Coronary Disease Diabetes Diabetes Mellitus Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Metabolic Diseases Myocardial Ischemia Nervous System Diseases Nutritional and Metabolic Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndrome Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The patient was diagnosed with coronary heart disease (coronary angiogram 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), and sleep apnea syndrome (≥ 5 apnea or hypoventilation events per hour during sleep, that is, AHI ≥ 5 times/hour, with associated symptoms or health risks. ）.

Exclusion criteria

Patients who have been implanted with permanent pacemakers; Patients with severe arrhythmia or myocardial infarction/stroke in the past 3 months; 48 hours prior to the experiment, the use of beta blockers, beta agonists ACE-I、ARB、 Patients with drugs such as adrenaline and dopamine; Pregnant women; Patients with serious diseases of important organs (such as heart, brain, kidney, liver, etc.); Patients with mental or physical disabilities; Unable to cooperate with patients undergoing examinations; Suspected or diagnosed patients with a history of alcohol or drug abuse; Patients with acute complications of diabetes, such as DKA, hypertonic coma, lactic acidosis, etc; Patients with thyroid dysfunction; Patients at risk of cardiac autonomic neuropathy (CAN), such as those with severe hypertension or proliferative retinopathy; Patients with electrolyte disorders such as hypokalemia.

Treatment and study plan

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

Primary outcomes

All-cause death event

Time frame: Follow up endpoint events after 3 years of enrollment.

Secondary outcomes

cardiovascular events

Time frame: Follow up endpoint events after 3 years of enrollment.

Sponsors and collaborators

Lead sponsor

Xiangtan Central Hospital

Other

Registry information

Official study title

The Effect of Autonomic Neuropathy Status on the Endpoint Events in Diabetes Patients With Coronary Heart Disease and Sleep Apnea: a Prospective Observational Cohort Study.

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2031
First posted: Jul 23, 2026
Registry last updated: Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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