ClinicalTrials.Veeva

Menu

Obstructive Sleep Apnoea in Patients With Type 1 Diabetes

U

University of Birmingham

Status

Completed

Conditions

Type 1 Diabetes
Obstructive Sleep Apnoea

Study type

Observational

Funder types

Other

Identifiers

NCT03481361
209532 (Other Identifier)
RG_16-154

Details and patient eligibility

About

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.

Full 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.

Enrollment

47 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems