Sleep Apnea in Type 1 Diabetes

NCT01935765 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2019-12-05

No results posted yet for this study

Summary

Sleep apnea syndrome is strongly associated to type 2 diabet, partly and this is partly due to obesity. Treatment of sleep apnea may improve hypertension, cardiovascular risk and in some studies diabetes status. Few data are available for type 1 diabetes but suggest that the prevalence of sleep apnea syndrome may be high. We plan to compare the prevalence of sleep apnea syndrome assessed by polysomnography in a sample of type 1 diabetic patients and a control group matched by age, gender and body mass index. The secondary objective is to determine if the presence of an autonomic neuropathy or poorly controlled diabetes (assessed by glycosylated haemoglobin) may or not contribute to the presence of sleep apnea in the diabetic group.

Conditions

  • Type 1 Diabetes, Sleep Apnea Syndrome

Interventions

OTHER

Polysomnography

Diabetes people: Examination diagnosis of the sleep apnea A night at the hospital

OTHER

Evaluation of the autonomous nervous system

blood pressure, Heart frequence, deep breath, Orthostatism, Vasalva, Low blood pressure orthostatic

OTHER

Clinical examination of the sleep

Functional signs, collection of medical histories and associated pathologies, Pittsburgh Sleep Quality Index PSQI, Functional Outcomes of Sleep Questionnaire FOSQ, Epworth Sleepiness Scale ESS, Hospital Anxiety and Depression scale HAD

OTHER

Clinical examination of diabetology

history of diabet, observance, ophthalmological, renal, macroangiopathic and neuronal complications, Toronto scale, Diabetes Quality of Life (DQOL) Questionnaire

OTHER

Biological dosages

Hematology, glycemia, lipids, CRP, creatinine, ferritin, glycosylated hemoglobin, transaminase, microalbuminuria, urine test

OTHER

Electrocardiogram (ECG)

Electrocardiogram (ECG)

OTHER

Carotid echography

Carotid echography

OTHER

Blood pressure

Blood pressure

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Véronique Viot-Blanc, MD · Lariboisiere Hospital, APHP

  • Pierre-Jean Guillausseau, MD, PhD · Lariboisiere Hopistal, APHP

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2019-06-30
Completion
2019-09-30

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 NCT01935765 on ClinicalTrials.gov