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

NCT03605329 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2021-10-07

No results posted yet for this study

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.

Conditions

  • Sleep Apnea, Obstructive
  • Diabetes Mellitus, Type 1

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • François Bughin, MD · University Hospital, Montpellier

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2020-01-30
Completion
2020-01-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03605329 on ClinicalTrials.gov