Clinical trial NCT01935765: Sleep Apnea in Type 1 Diabetes
Official title: Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes, Sleep Apnea Syndrome
Keywords: Type 1 diabetes, sleep apnea, polysomnography,
autonomic neuropathy, intima media thickness
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2013-09-05
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers
timeFrame: 3 months
Secondary outcomes:
measure: Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome
timeFrame: 3 months
measure: Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome
timeFrame: 3 months
measure: Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors
timeFrame: 3 months
measure: Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy
timeFrame: 3 months
measure: Precise clinical symptoms in DT1 patients with Sleep apnea syndrome
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Véronique Viot-Blanc
state: Ile De France
Study officials:
affiliation: Lariboisiere Hospital, APHP
name: Véronique Viot-Blanc, MD
role: STUDY_DIRECTOR
affiliation: Lariboisiere Hopistal, APHP
name: Pierre-Jean Guillausseau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: