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

NCT07723222 | Not Yet Recruiting

• 1 other identifier: CHD+DM+OSA
• Study Type: observational
• Target: 326
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• All-cause death event

  Follow up endpoint events after 3 years of enrollment.

Secondary Outcomes (1)

• cardiovascular events

  Follow up endpoint events after 3 years of enrollment.

Study Arms (2)

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

Non-CAN group

Non-Cardiovascular autonomic neuropathy group

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

CAN group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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. ）.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xiangtan Central Hospital: lead

Related Publications (1)

• Pop-Busui R, Braffett BH, Zinman B, Martin C, White NH, Herman WH, Genuth S, Gubitosi-Klug R; DCCT/EDIC Research Group. Cardiovascular Autonomic Neuropathy and Cardiovascular Outcomes in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study. Diabetes Care. 2017 Jan;40(1):94-100. doi: 10.2337/dc16-1397. Epub 2016 Nov 1.

  PMID: 27803120 RESULT

MeSH Terms

Conditions

Coronary Disease; Diabetes Mellitus; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean, Xiangtan Central Hospital ,Director of cardiovascular clinic, Clinical Professor

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 23, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL