Sleep Apnea in Type 1 Diabetes (DIASOM)

This study is currently recruiting participants.
Verified April 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01935765
First received: September 2, 2013
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes, Sleep Apnea Syndrome
Other: Polysomnography
Other: Evaluation of the autonomous nervous system
Other: Clinical examination of the sleep
Other: Clinical examination of diabetology
Other: Biological dosages
Other: Electrocardiogram (ECG)
Other: Carotid echography
Other: Blood pressure
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compare diabetic subjects with or without sleep apnea regarding the rate of poorly controlled diabetes (determined by the level of glycosylated haemoglobin)

  • Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compare diabetic subjects with or without sleep apnea regarding presence of autonomic neuropathy determined by clinical assessment

  • Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compare diabetic subjects with or without sleep apnea regarding other cardiovascular risk factors and consequences (intima media thickness)

  • Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Compare diabetic subjects with or without sleep apnea regarding quality of sleep

  • Precise clinical symptoms in DT1 patients with Sleep apnea syndrome [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 145
Study Start Date: September 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diabetes people
99 Type 1 diabetic patients aged 18 to 60 years, diagnosed since at least a year
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
Experimental: healthy volunteers (controll group)
46 healthy volunteers matched by age, gender and body mass index
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: 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

Detailed Description:

Diagnostic protocol designed to evaluate if if sleep apnea syndrome is more frequent in type 1 diabetes than in general population and therefore deserves to be more systematically suspected and actively diagnosed in this patients. Sleep apnea syndrome is a heavy burden as a matter of quality of life: it is responsible for fatigue, diurnal sleepiness, cognitive impairment, poor and /or non restorative sleep, morning headaches, depressive mood…Adequate treatment provides a rapid and, most of the time, complete relief of these symptoms.

On an other hand, Sleep Apnea is and independent risk factor for cardiovascular mortality and morbidity in young and middle aged subjects, also reversed by treatment. It might be therefore important for type 1 diabetic patients who have already an increased cardiovascular risk to be properly diagnosed for sleep apnea. A systematic screening for sleep apnea is already recommended for patients with type 2 diabetes by experts.

A secondary objective is to determine if the presence of a sleep apnea syndrome in type 1 diabetic patients is associated to an autonomic neuropathy, a poor glycemic control , a poorer quality of life , a poorer quality of sleep, more severe cardiovascular consequences and biological impairment.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 99 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

Exclusion Criteria:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01935765

Contacts
Contact: Véronique Viot-Blanc, MD +33 1 49 95 83 14 veronique.viot-blanc@lrb.aphp.fr
Contact: Pierre- Jean Guillausseau, MD, PhD +33 1 49 95 63 80 pierre-jean.guillausseau@lrb.aphp.fr

Locations
France
Véronique Viot-Blanc Recruiting
Paris, Ile de France, France, 75010
Contact: Véronique Viot-Blanc, MD    +33 1 49 95 83 14    veronique.viot-blanc@lrb.aphp.fr   
Principal Investigator: Véronique Viot-Blanc, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Investigators
Study Director: Véronique Viot-Blanc, MD Lariboisiere Hospital, APHP
Principal Investigator: Pierre-Jean Guillausseau, MD, PhD Lariboisiere Hopistal, APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01935765     History of Changes
Other Study ID Numbers: P111009
Study First Received: September 2, 2013
Last Updated: April 11, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Type 1 diabetes, sleep apnea, polysomnography,
autonomic neuropathy, intima media thickness

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Disorders, Intrinsic
Sleep Disorders
Diabetes Mellitus
Diabetes Mellitus, Type 1
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Dyssomnias
Nervous System Diseases

ClinicalTrials.gov processed this record on April 15, 2014