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

NCT03605329 | Terminated

• 1 other identifier: UF 9801
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive; Diabetes Mellitus, Type 1

Keywords

Sleep Apnea, Obstructive; diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluation of the severity of CAN

  day 1

• measurements of sweat gland dysfunction

  day 1

• Characterization of the sleep architecture of T1D patients

  day 1

• monitoring of blood pressure

  day 1

Study Arms (1)

Type 1 diabetic patients with OSAS

OTHER

to explore the severity of NAC in case of OSAS

Other: to explore the severity of NAC in case of OSAS

Interventions

to explore the severity of NAC in case of OSAS OTHER

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.

Type 1 diabetic patients with OSAS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 1 diabetes patients with a diabetes duration of at least 5 years
• Age between 18 and 60 years old.

You may not qualify if:

• OSAS treated with CPAP
• Chronic alcoholism
• Neuromuscular disease
• Drugs interfering with sinus variability (betablockers, antiarrhythmics, ivabradine), presence of pacemaker
• Pregant woman

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

CHU Montpellier

Montpellier, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• François Bughin, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 30, 2018
• Study Start: September 5, 2018
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: October 7, 2021

Record last verified: 2021-09

Locations

FR (1)