Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
NCT ID: NCT03605329
Last Updated: 2021-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
23 participants
INTERVENTIONAL
2018-09-05
2020-01-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Obstructive Sleep Apnoea in Patients With Type 1 Diabetes
NCT03481361
Prevalence of Sleep Apnea Syndrome in Patients With Type 1 Diabetes
NCT03506022
Sleep Apnea, Coronary Atherosclerosis and Heart Failure in Diabetes Patients With Nephropathy
NCT04549324
Prevalence of Obstructive Sleep Apnea Syndrome in Type 1 Diabetic Patients Treated With Insulin Pump (At1Home)
NCT02796534
Autonomic Function in Obstructive Sleep Apnea
NCT00681161
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Type 1 diabetic patients with OSAS
to explore the severity of NAC in case of OSAS
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age between 18 and 60 years old.
Exclusion Criteria
* Chronic alcoholism
* Neuromuscular disease
* Drugs interfering with sinus variability (betablockers, antiarrhythmics, ivabradine), presence of pacemaker
* Pregant woman
18 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
François Bughin, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Montpellier
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UF 9801
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.