Obstructive Sleep Apnoea (OSA) in Patients With Type 1 Diabetes (T1D): A Cross-Sectional Study

Obstructive Sleep Apnoea in Patients With Type 1 Diabetes

Sponsors

Lead sponsor: University of Birmingham

Collaborator: Heart of England NHS Trust

Source 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.

Overall Status Recruiting
Start Date February 14, 2018
Completion Date September 2019
Primary Completion Date September 2019
Study Type Observational
Primary Outcome
Measure Time Frame
The relationship between OSA and cardiac autonomic neuropathy (CAN) in patients with T1D. Single time point measurement (20- 30 min)
Secondary Outcome
Measure Time Frame
The prevalence of obstructive sleep apnoea in patients with T1D. Single time point measurement (over 8 hours) at participant residence
The relationship between the presence of OSA and metabolic profile in patients with T1D. Single time point measurement (15 min)
The relationship between OSA and the presence of microvascular complications in T1D patients. Single time point measurement (1-2 hours)
The potential mechanisms for the relationship between OSA and diabetic-related complications Single time point measurement (about 5 min)
Enrollment 190
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Abd Tahrani, MD Principal Investigator NIHR Clinician Scientist at University of Birmingham
Overall Contact

Last name: Abd Tahrani, MD

Phone: +441214158705

Email: [email protected]

Location
facility status contact investigator Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust Ziyad Alshehri, MSc Abd Tahrani, MD Principal Investigator
Location Countries

United Kingdom

Verification Date

April 2019

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Observational model: Cohort

Time perspective: Cross-Sectional

Source: ClinicalTrials.gov