Obstructive Sleep Apnoea in Patients With Type 1 Diabetes

NCT03481361 | Completed

• 2 other identifiers: RG_16-154209532
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes; Obstructive Sleep Apnoea

Keywords

Obstructive sleep apnoea (OSA); Type 1 diabetes (T1D); Type 2 diabetes (T2D); Insulin-Dependent Diabetes Mellitus (IDDM)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Birmingham: lead
• Heart of England NHS Trust: collaborator

Study Sites (1)

Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

Location

Related Publications (6)

• Borel AL, Benhamou PY, Baguet JP, Halimi S, Levy P, Mallion JM, Pepin 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. No abstract available.

  PMID: 20950392 BACKGROUND

• 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.

  PMID: 22048845 BACKGROUND

• 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.

  PMID: 25186832 BACKGROUND

• 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.

  PMID: 24628249 BACKGROUND

• 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.

  PMID: 21679352 BACKGROUND

• 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.

  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum and Plasma

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Sleep Apnea, Obstructive; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Abd Tahrani, MD

  NIHR Clinician Scientist at University of Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: March 29, 2018
• Study Start: February 14, 2018
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: September 7, 2020

Record last verified: 2020-08

Locations

GB (1)