Sleep Apnea in Type 1 Diabetes

Type 1 Diabetes, Sleep Apnea Syndrome Clinical Trial

— DIASOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935765
• Other study ID #: P111009
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: September 2019

Study information

• Verified date: December 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: September 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Sleep Apnea Syndromes
• Type 1 Diabetes, Sleep Apnea Syndrome

Intervention

Other:
• Polysomnography
Diabetes people: Examination diagnosis of the sleep apnea A night at the hospital
• Evaluation of the autonomous nervous system
blood pressure, Heart frequence, deep breath, Orthostatism, Vasalva, Low blood pressure orthostatic
• 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
• Clinical examination of diabetology
history of diabet, observance, ophthalmological, renal, macroangiopathic and neuronal complications, Toronto scale, Diabetes Quality of Life (DQOL) Questionnaire
• Biological dosages
Hematology, glycemia, lipids, CRP, creatinine, ferritin, glycosylated hemoglobin, transaminase, microalbuminuria, urine test
• Electrocardiogram (ECG)
Electrocardiogram (ECG)
• Carotid echography
Carotid echography
• Blood pressure
Blood pressure

Locations

Country	Name	City	State
France	Véronique Viot-Blanc	Paris	Ile De France

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Precise clinical symptoms in DT1 patients with Sleep apnea syndrome		3 months