NCT01935765

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 5, 2013

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 5, 2019

Status Verified

December 1, 2019

Enrollment Period

5.8 years

First QC Date

September 2, 2013

Last Update Submit

December 4, 2019

Conditions

Type 1 Diabetes, Sleep Apnea Syndrome

Keywords

Type 1 diabetes, sleep apnea, polysomnography,autonomic neuropathy, intima media thickness

Outcome Measures

Primary Outcomes (1)

  • Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers

    Determine if prevalence of the sleep apnea syndrome is more raised at the patient's diabetics of type 1 (DT1) than in the general population and to collect elements to specify the determiners of this association (presence of an autonomous neuropathy and glycemic balance). sleep apnea syndrome as defined by the International Classification of Sleep Disorders 2

    3 months

Secondary Outcomes (5)

  • Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome

    3 months

  • Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome

    3 months

  • Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors

    3 months

  • Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy

    3 months

  • Precise clinical symptoms in DT1 patients with Sleep apnea syndrome

    3 months

Study Arms (2)

Diabetes people

EXPERIMENTAL

99 Type 1 diabetic patients aged 18 to 60 years, diagnosed since at least a year

Other: PolysomnographyOther: Evaluation of the autonomous nervous systemOther: Clinical examination of the sleepOther: Clinical examination of diabetologyOther: Biological dosagesOther: Electrocardiogram (ECG)Other: Carotid echographyOther: Blood pressure

healthy volunteers (controll group)

EXPERIMENTAL

46 healthy volunteers matched by age, gender and body mass index

Other: PolysomnographyOther: Evaluation of the autonomous nervous systemOther: Clinical examination of the sleepOther: Biological dosagesOther: Electrocardiogram (ECG)Other: Carotid echographyOther: Blood pressure

Interventions

PolysomnographyOTHER

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

Diabetes peoplehealthy volunteers (controll group)
Evaluation of the autonomous nervous systemOTHER

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

Diabetes peoplehealthy volunteers (controll group)
Clinical examination of the sleepOTHER

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

Diabetes peoplehealthy volunteers (controll group)
Clinical examination of diabetologyOTHER

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

Diabetes people
Biological dosagesOTHER

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

Diabetes peoplehealthy volunteers (controll group)
Electrocardiogram (ECG)OTHER

Electrocardiogram (ECG)

Diabetes peoplehealthy volunteers (controll group)
Carotid echographyOTHER

Carotid echography

Diabetes peoplehealthy volunteers (controll group)
Blood pressureOTHER

Blood pressure

Diabetes peoplehealthy volunteers (controll group)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 diabetic patients
  • man or woman aged 18 to 60 years
  • diagnosed since at least a year
  • having signed a consent
  • with in a national insurance scheme
  • and 46 healthy volunteers matched by age , gender and body mass index
  • man or woman aged 18 to 60 years
  • having signed a consent
  • with in a national insurance scheme

You may not qualify if:

  • for both
  • sleep apnea syndrome already known
  • acute respiratory or cardiovascular disease
  • impairment of consciousness
  • sepsis
  • cirrhosis
  • hypnotic, opiate or psychotropic drug treatment 2 weeks ago
  • Pregnant or breast-feeding woman
  • Do not speak French
  • Benefiting from a legal protective measure
  • diabet 1 or 2 just for volunteers people

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Véronique Viot-Blanc

Paris, Île-de-France Region, 75010, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Sleep Apnea Syndromes

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Vital SignsPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Véronique Viot-Blanc, MD

    Lariboisiere Hospital, APHP

    STUDY DIRECTOR

  • Pierre-Jean Guillausseau, MD, PhD

    Lariboisiere Hopistal, APHP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2013

First Posted

September 5, 2013

Study Start

September 1, 2013

Primary Completion

June 1, 2019

Study Completion

September 1, 2019

Last Updated

December 5, 2019

Record last verified: 2019-12

Locations

FR(1)