Sleep Apnea in Type 1 Diabetes (DIASOM)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Type 1 Diabetes, Sleep Apnea Syndrome

Treatments: Other: Carotid echography; Other: Electrocardiogram (ECG); Other: Blood pressure; Other: Evaluation of the autonomous nervous system; Other: Clinical examination of the sleep; Other: Polysomnography; Other: Biological dosages; Other: Clinical examination of diabetology

Study type: Interventional

Funder types: Other

Identifiers

NCT01935765

P111009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Diabetes people

Experimental group

Description:

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

Treatment:

Other: Biological dosages

Other: Evaluation of the autonomous nervous system

Other: Blood pressure

Other: Carotid echography

Other: Electrocardiogram (ECG)

Other: Clinical examination of diabetology

Other: Clinical examination of the sleep

Other: Polysomnography

healthy volunteers (controll group)

Experimental group

Description:

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

Treatment:

Other: Biological dosages

Other: Evaluation of the autonomous nervous system

Other: Blood pressure

Other: Carotid echography

Other: Electrocardiogram (ECG)

Other: Clinical examination of the sleep

Other: Polysomnography