Obstructive Sleep Apnoea in Patients With Type 1 Diabetes
- Conditions
- Obstructive Sleep ApnoeaType 1 Diabetes
- Registration Number
- NCT03481361
- Lead Sponsor
- University of Birmingham
- Brief Summary
The primary aim of this study is to assess the relationship between obstructive sleep apnoea (OSA) and cardiac autonomic neuropathy (CAN) in patients with T1D.
The secondary aims of this study are to assess: (1) the prevalence of OSA in patients with T1D; (2) the relationship between OSA and metabolic parameters (such as glycaemic control, blood pressure, lipids and weight) in patients with T1D; (3) the relationship between OSA and diabetes-related microvascular complications (retinopathy, nephropathy, peripheral neuropathy) in patients with T1D; and (4) the potential mechanisms for the relationship between OSA and diabetic-related complications if such a relationship is found.
- Detailed Description
Obstructive sleep apnoea (OSA) has been reported to be very common in patient with type 2 diabetes (T2D), and this relation is expected as both conditions share obesity as a common risk factor. Despite that several articles have stated that OSA is an independent risk factor for abnormal glucose metabolism, hypertension, and cardiovascular diseases.
In contrast, patients with type 1 diabetes (T1D) are leaner and younger than patients with T2D, so it was expected that OSA might be less common in patients with T1D. However, few studies have reported the prevalence of OSA in T1D with a range between 8 and 46%. The relationship between OSA and diabetes-related vascular disease is poorly explored in patients with T1D. This suggests a mechanism other than obesity may be responsible for OSA in patients with T1D. Therefore, the investigators hypothesized that (1) OSA is related to CAN rather than obesity in patients with T1D. (2) OSA is common in patients with T1D. (3) OSA is associated with worse metabolic profile and microvascular complications in T1D. (4) Oxidative and nitrosative stress are possible mechanisms relating OSA to T1D complication.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- T1DM patient aged 18 and above, who was diagnosed more than 4 years ago.
- Able to give informed consent.
- Has sufficient proficiency in English to verbally answer interview questions.
- Past medical history of severe respiratory disorders including treated OSA.
- Patients using oxygen supplements.
- Patients with end-stage renal disease receiving dialysis.
- Pregnancy.
- Dementia.
- End stage diseases with life expectancy below 6 months.
- Patients with implantable devices
- Patients with known atrial fibrillation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The relationship between OSA and cardiac autonomic neuropathy (CAN) in patients with T1D. Single time point measurement (20- 30 min) CAN will be assessed using heart rate variability (HRV) and spectral analysis. During this test blood pressure and electrocardiogram (ECG) and will be recorded while resting in a sitting down position and during certain manoeuvres that include deep breathing and Valsalva, and standing up. The Result of this outcome will be categorized into normal, borderline, or abnormal.
This study is one visit only, and the total duration of the visit is 2-4 hours. The time frame below is the approximate time needed to collect each outcome data.
- Secondary Outcome Measures
Name Time Method The prevalence of obstructive sleep apnoea in patients with T1D. Single time point measurement (over 8 hours) at participant residence Sleep apnoea will be assessed using portable multi-channel home-based sleep device.
The relationship between the presence of OSA and metabolic profile in patients with T1D. Single time point measurement (15 min) This outcome will be assessed by comparing the routine assessment results for patients with OSA to patients without OSA.
The relationship between OSA and the presence of microvascular complications in T1D patients. Single time point measurement (1-2 hours) Microvascular complications include diabetic neuropathy, diabetic nephropathy, and diabetic retinopathy.
The potential mechanisms for the relationship between OSA and diabetic-related complications Single time point measurement (about 5 min) Will be assessed using serum and plasma blood samples.
Trial Locations
- Locations (1)
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust
🇬🇧Birmingham, United Kingdom