Obstructive Sleep Apnoea in Patients With Type 1 Diabetes

September 4, 2020 updated by: University of Birmingham

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

47

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be patients with type 1 diabetes attending secondary care diabetes clinics at Heart of England NHS Foundation Trust (HEFT) in Birmingham.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between OSA and cardiac autonomic neuropathy (CAN) in patients with T1D.
Time Frame: 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.
Single time point measurement (20- 30 min)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The prevalence of obstructive sleep apnoea in patients with T1D.
Time Frame: Single time point measurement (over 8 hours) at participant residence
Sleep apnoea will be assessed using portable multi-channel home-based sleep device.
Single time point measurement (over 8 hours) at participant residence
The relationship between the presence of OSA and metabolic profile in patients with T1D.
Time Frame: 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.
Single time point measurement (15 min)
The relationship between OSA and the presence of microvascular complications in T1D patients.
Time Frame: Single time point measurement (1-2 hours)
Microvascular complications include diabetic neuropathy, diabetic nephropathy, and diabetic retinopathy.
Single time point measurement (1-2 hours)
The potential mechanisms for the relationship between OSA and diabetic-related complications
Time Frame: Single time point measurement (about 5 min)
Will be assessed using serum and plasma blood samples.
Single time point measurement (about 5 min)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Birmingham

Collaborators

Heart of England NHS Trust

Investigators

  • Principal Investigator: Abd Tahrani, MD, NIHR Clinician Scientist at University of Birmingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2018

Primary Completion (Actual)

June 27, 2019

Study Completion (Actual)

June 27, 2019

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 29, 2018

Study Record Updates

Last Update Posted (Actual)

September 7, 2020

Last Update Submitted That Met QC Criteria

September 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG_16-154
  • 209532 (Other Identifier: Integrated Research Approval System (IRAS))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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