Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS (DIADYSAS)
Primary Purpose
Sleep Apnea, Obstructive, Diabetes Mellitus, Type 1
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
to explore the severity of NAC in case of OSAS
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea, Obstructive focused on measuring Sleep Apnea, Obstructive, diabetes
Eligibility Criteria
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
Sites / Locations
- CHU Montpellier
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Type 1 diabetic patients with OSAS
Arm Description
to explore the severity of NAC in case of OSAS
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Evaluation of the severity of CAN
measurements of urinary levels of catecholamines
measurements of sweat gland dysfunction
Sudoscan
Characterization of the sleep architecture of T1D patients
overnight polysomnography
monitoring of blood pressure
a 24-hour monitoring of blood pressure
Full Information
NCT ID
NCT03605329
First Posted
July 9, 2018
Last Updated
September 29, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03605329
Brief Title
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
Acronym
DIADYSAS
Official Title
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With Obstructive Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
recruitment rate lower than expected
Study Start Date
September 5, 2018 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Diabetes Mellitus, Type 1
Keywords
Sleep Apnea, Obstructive, diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 1 diabetic patients with OSAS
Arm Type
Other
Arm Description
to explore the severity of NAC in case of OSAS
Intervention Type
Other
Intervention Name(s)
to explore the severity of NAC in case of OSAS
Intervention Description
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.
Primary Outcome Measure Information:
Title
study of heart rate variability (HRV)
Description
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.
Time Frame
day 1
Secondary Outcome Measure Information:
Title
Evaluation of the severity of CAN
Description
measurements of urinary levels of catecholamines
Time Frame
day 1
Title
measurements of sweat gland dysfunction
Description
Sudoscan
Time Frame
day 1
Title
Characterization of the sleep architecture of T1D patients
Description
overnight polysomnography
Time Frame
day 1
Title
monitoring of blood pressure
Description
a 24-hour monitoring of blood pressure
Time Frame
day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François Bughin, MD
Organizational Affiliation
University Hospital, Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
Country
France
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
We'll reach out to this number within 24 hrs