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NCT Number: NCT03481361

Obstructive Sleep Apnoea in Patients With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Apnea Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Obstructive Sleep Apnoea Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Heart of England NHS Trust

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Sep 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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