Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS

Diabetes Mellitus, Type 1 Clinical Trial

— DIADYSAS  

Official title:

Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03605329
• Other study ID #: UF 9801
• Status: Terminated
• Phase: N/A
• Start date: September 5, 2018
• Est. completion date: January 30, 2020

Study information

• Verified date: September 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The links between obstructive sleep apnea syndrome (OSAS) and type 1 diabetes (T1D) are poorly studied. This study proposes to evaluate the severity of cardiovascular autonomic neuropathy (CAN) related to T1D in case of associated OSAS. This issue has significant diagnostic and therapeutic implications because of the increased cardiovascular risk in case of confirmed CAN in T1D patients.

Description:

Cardiovascular autonomic neuropathy (CAN) is a common complication of type 1 diabetes (T1D) and is associated with increased cardiovascular risk. Otherwise, some studies have found a high frequence of obstructive sleep apnea syndrome (OSAs) in T1D. Cardiac autonomic modulations are deeply altered in OSAS. The combination of T1D and OSAS could therefore increase the severity of CAN and worsen the cardiovascular prognosis.

The most common method used to explore CAN is the study of heart rate variability (HRV). HRV is a practical, non-invasive and reproducible measure of autonomic nervous system function. HRV abnormalities are a predictor of hypertension and increased mortality in T1D.

Th investigators therefore propose to explore the severity of NAC in case of OSAS associated with T1D, and the hypothesis is that cardiovascular damage is increased in the presence of these two pathologies.

The patients included in this study will be patients with type 1 diabetes diagnosed for more than 5 years.

After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan.

The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour.

Furthermore, glycemic holter will describe the links between glycemic variability, sleep architecture and CAN. Biological oxidative stress assays will improve physiopathological knowledge between T1D, OSAS and CAN. Finally, a 24-hour monitoring of blood pressure will be performed.

An ancillary study is planned to evaluate the evolution of markers of the autonomic nervous system after three months of treatment with CPAP in 15 patients with severe OSAS (AHI ≥30 / hour) having previously participated in the main study. Fifteen patients with IAH <30 / hour will also be reassessed at three months to assess the intra-individual variability of the HRV.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: January 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion criteria:

• Type 1 diabetes patients with a diabetes duration of at least 5 years

• Age between 18 and 60 years old.

Exclusion criteria:

• OSAS treated with CPAP

• Chronic alcoholism

• Neuromuscular disease

• Drugs interfering with sinus variability (betablockers, antiarrhythmics, ivabradine), presence of pacemaker

• Pregant woman

Related Conditions & MeSH terms

• Apnea
• Diabetes Mellitus, Type 1
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• to explore the severity of NAC in case of OSAS
After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan. The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) =15 / hour) compared to T1D patients with IAH <15 / hour.

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	study of heart rate variability (HRV)	heart rate variability (LF/HF ratio) in type 1 diabetic patients with sleep apnea syndrome (AHI>15/h) in comparison with T1D patients with AHI <15/hour.	day 1
Secondary	Evaluation of the severity of CAN	measurements of urinary levels of catecholamines	day 1
Secondary	measurements of sweat gland dysfunction	Sudoscan	day 1
Secondary	Characterization of the sleep architecture of T1D patients	overnight polysomnography	day 1
Secondary	monitoring of blood pressure	a 24-hour monitoring of blood pressure	day 1