Obstructive Sleep Apnoea in Patients With Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03481361
• Other study ID #: RG_16-154
• Secondary ID: 209532
• Status: Completed
• Start date: February 14, 2018
• Est. completion date: June 27, 2019

Study information

• Verified date: August 2020
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 27, 2019
• Est. primary completion date: June 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Type 1 Diabetes

Locations

Country	Name	City	State
United Kingdom	Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust	Birmingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Birmingham	Heart of England NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (6)

Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pépin JL. High prevalence of obstructive sleep apnoea syndrome in a Type 1 diabetic adult population: a pilot study. Diabet Med. 2010 Nov;27(11):1328-9. doi: 10.1111/j.1464-5491.2010.03096.x. — View Citation

Golbidi S, Badran M, Ayas N, Laher I. Cardiovascular consequences of sleep apnea. Lung. 2012 Apr;190(2):113-32. doi: 10.1007/s00408-011-9340-1. Epub 2011 Nov 3. Review. — View Citation

Manin G, Pons A, Baltzinger P, Moreau F, Iamandi C, Wilhelm JM, Lenoble P, Kessler L, Kessler R. Obstructive sleep apnoea in people with Type 1 diabetes: prevalence and association with micro- and macrovascular complications. Diabet Med. 2015 Jan;32(1):90-6. doi: 10.1111/dme.12582. Epub 2014 Sep 25. — View Citation

Reutrakul S, Van Cauter E. Interactions between sleep, circadian function, and glucose metabolism: implications for risk and severity of diabetes. Ann N Y Acad Sci. 2014 Apr;1311:151-73. doi: 10.1111/nyas.12355. Epub 2014 Mar 14. Review. — View Citation

Schober AK, Neurath MF, Harsch IA. Prevalence of sleep apnoea in diabetic patients. Clin Respir J. 2011 Jul;5(3):165-72. doi: 10.1111/j.1752-699X.2010.00216.x. Epub 2010 Jun 30. — View Citation

Tahrani AA. Obstructive sleep apnea in patients with diabetes: implications for clinical practice. Diabetes Management. 2015; 5(6):511-23. doi: 10.2217/dmt.15.34.

Outcome

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