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

July 22, 2026 updated by: Jianping Zeng, Xiangtan Central Hospital

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.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

326

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Effect of autonomic neuropathy status on end point events in type 2 diabetes patients with coronary heart disease and sleep apnea.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CAN group
Cardiovascular autonomic neuropathy group
Behavioral: 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

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
Non-CAN group
Non-Cardiovascular autonomic neuropathy group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
cardiovascular events
Time Frame: Follow up endpoint events after 3 years of enrollment.
Follow up endpoint events after 3 years of enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiangtan Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2031

Study Registration Dates

First Submitted

July 20, 2026

First Submitted That Met QC Criteria

July 22, 2026

First Posted (Actual)

July 23, 2026

Study Record Updates

Last Update Posted (Actual)

July 23, 2026

Last Update Submitted That Met QC Criteria

July 22, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHD+DM+OSA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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