Sleep Apnea in Type 1 Diabetes (DIASOM)

Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes, Sleep Apnea Syndrome
• Intervention / Treatment: 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

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75010
      • Véronique Viot-Blanc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome	Compare diabetic subjects with or without sleep apnea regarding the rate of poorly controlled diabetes (determined by the level of glycosylated haemoglobin)	3 months
Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome	Compare diabetic subjects with or without sleep apnea regarding presence of autonomic neuropathy determined by clinical assessment	3 months
Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors	Compare diabetic subjects with or without sleep apnea regarding other cardiovascular risk factors and consequences (intima media thickness)	3 months
Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy	Compare diabetic subjects with or without sleep apnea regarding quality of sleep	3 months
Precise clinical symptoms in DT1 patients with Sleep apnea syndrome		3 months

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Ministry of Health, France
• Investigators: Study Director: Véronique Viot-Blanc, MD, Lariboisière Hospital, APHP; Principal Investigator: Pierre-Jean Guillausseau, MD, PhD, Lariboisiere Hopistal, APHP

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: September 2, 2013
• First Submitted That Met QC Criteria: September 2, 2013
• First Posted (Estimate): September 5, 2013

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Type 1 diabetes, sleep apnea, polysomnography,; autonomic neuropathy, intima media thickness
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Diabetes Mellitus; Diabetes Mellitus, Type 1; Apnea
• Other Study ID Numbers: P111009