Sleep Apnea in Type 1 Diabetes (DIASOM)
Primary Purpose
Type 1 Diabetes, Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polysomnography
Evaluation of the autonomous nervous system
Clinical examination of the sleep
Clinical examination of diabetology
Biological dosages
Electrocardiogram (ECG)
Carotid echography
Blood pressure
Sponsored by
About this trial
This is an interventional diagnostic trial for Type 1 Diabetes, Sleep Apnea Syndrome focused on measuring Type 1 diabetes, sleep apnea, polysomnography,, autonomic neuropathy, intima media thickness
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
Sites / Locations
- Véronique Viot-Blanc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diabetes people
healthy volunteers (controll group)
Arm Description
99 Type 1 diabetic patients aged 18 to 60 years, diagnosed since at least a year
46 healthy volunteers matched by age, gender and body mass index
Outcomes
Primary Outcome Measures
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
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
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
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
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
Compare diabetic subjects with or without sleep apnea regarding quality of sleep
Precise clinical symptoms in DT1 patients with Sleep apnea syndrome
Full Information
NCT ID
NCT01935765
First Posted
September 2, 2013
Last Updated
December 4, 2019
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT01935765
Brief Title
Sleep Apnea in Type 1 Diabetes
Acronym
DIASOM
Official Title
Sleep Apnea in Type 1 Diabetes : Prevalence, Role of Glycemic Control and Autonomic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Ministry of Health, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Sleep Apnea Syndrome
Keywords
Type 1 diabetes, sleep apnea, polysomnography,, autonomic neuropathy, intima media thickness
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diabetes people
Arm Type
Experimental
Arm Description
99 Type 1 diabetic patients aged 18 to 60 years, diagnosed since at least a year
Arm Title
healthy volunteers (controll group)
Arm Type
Experimental
Arm Description
46 healthy volunteers matched by age, gender and body mass index
Intervention Type
Other
Intervention Name(s)
Polysomnography
Intervention Description
Diabetes people: Examination diagnosis of the sleep apnea A night at the hospital
Intervention Type
Other
Intervention Name(s)
Evaluation of the autonomous nervous system
Intervention Description
blood pressure, Heart frequence, deep breath, Orthostatism, Vasalva, Low blood pressure orthostatic
Intervention Type
Other
Intervention Name(s)
Clinical examination of the sleep
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Clinical examination of diabetology
Intervention Description
history of diabet, observance, ophthalmological, renal, macroangiopathic and neuronal complications, Toronto scale, Diabetes Quality of Life (DQOL) Questionnaire
Intervention Type
Other
Intervention Name(s)
Biological dosages
Intervention Description
Hematology, glycemia, lipids, CRP, creatinine, ferritin, glycosylated hemoglobin, transaminase, microalbuminuria, urine test
Intervention Type
Other
Intervention Name(s)
Electrocardiogram (ECG)
Intervention Description
Electrocardiogram (ECG)
Intervention Type
Other
Intervention Name(s)
Carotid echography
Intervention Description
Carotid echography
Intervention Type
Other
Intervention Name(s)
Blood pressure
Intervention Description
Blood pressure
Primary Outcome Measure Information:
Title
Compare the prevalence of sleep apnea syndrome by polysomnography between type 1 diabetic patients and healthy volunteers
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Precise if glycemic balance as defined by glycosylated hemoglobin<7% during the last three months is associated or not to sleep apnea syndrome
Description
Compare diabetic subjects with or without sleep apnea regarding the rate of poorly controlled diabetes (determined by the level of glycosylated haemoglobin)
Time Frame
3 months
Title
Precise if the presence of an autonomic neuropathy (positive at 2 tests) is associated or not to sleep apnea syndrome
Description
Compare diabetic subjects with or without sleep apnea regarding presence of autonomic neuropathy determined by clinical assessment
Time Frame
3 months
Title
Compare the patients with or without sleep apnea regarding consequences especially cardiovascular markers and coagulation factors
Description
Compare diabetic subjects with or without sleep apnea regarding other cardiovascular risk factors and consequences (intima media thickness)
Time Frame
3 months
Title
Determine if the presence of sleep apnea syndrome has an impact upon quality of life and diabetes complications, micro or macroangiopathy
Description
Compare diabetic subjects with or without sleep apnea regarding quality of sleep
Time Frame
3 months
Title
Precise clinical symptoms in DT1 patients with Sleep apnea syndrome
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Véronique Viot-Blanc, MD
Organizational Affiliation
Lariboisiere Hospital, APHP
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Pierre-Jean Guillausseau, MD, PhD
Organizational Affiliation
Lariboisiere Hopistal, APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Véronique Viot-Blanc
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75010
Country
France
12. IPD Sharing Statement
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Sleep Apnea in Type 1 Diabetes
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