Type 1 DiabetesNCT03481361
Obstructive Sleep Apnoea in Patients With Type 1 Diabetes
An observational study of Type 1 Diabetes and Obstructive Sleep Apnoea, run by University of Birmingham at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Obstructive Sleep Apnoea
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2018to 27 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Birmingham Heartlands Hospital, Heart of England NHS Foundation Trust
Birmingham, B9 5SS
About this study
Official title: 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.
Read the 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.
- 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)
- Medical subject headings
- Diabetes Mellitus, Type 1, Sleep Apnea, Obstructive, Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Single time point measurement (20- 30 min)
Secondary outcomes (4)
The prevalence of obstructive sleep apnoea in patients with T1D.
Sleep apnoea will be assessed using portable multi-channel home-based sleep device.
Measured: Single time point measurement (over 8 hours) at participant residence
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.
Measured: Single time point measurement (15 min)
The relationship between OSA and the presence of microvascular complications in T1D patients.
Microvascular complications include diabetic neuropathy, diabetic nephropathy, and diabetic retinopathy.
Measured: Single time point measurement (1-2 hours)
The potential mechanisms for the relationship between OSA and diabetic-related complications
Will be assessed using serum and plasma blood samples.
Measured: Single time point measurement (about 5 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start14 Feb 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Heart of England NHS Trust
- Responsible party
- Sponsor
- Investigators
- Abd Tahrani, MD, Principal investigator, NIHR Clinician Scientist at University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481361
- Sponsor's protocol ID
- RG_16-154
- Other IDs
- 209532
- Status last verified
- Aug 2020
- First submitted
- 5 Mar 2018
- Last updated
- 7 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 20950392Golbidi 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.
PubMed 22048845Manin 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.
PubMed 25186832Reutrakul 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.
PubMed 24628249Schober 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.
PubMed 21679352Tahrani 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Sleep Apnoea (OSA) in Patients With Type 1 Diabetes (T1D): A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT03481361
- Acronym / sponsor ID
- RG_16-154
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- Heart of England NHS Trust
- Study start
- 14 Feb 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Past medical history of severe respiratory disorders including treated OSA.
- Patients using oxygen supplements.
- Patients with end-stage renal disease receiving dialysis.
- Pregnancy.
- Dementia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
The prevalence of obstructive sleep apnoea in patients with T1D.
Time frame: 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)
The relationship between OSA and the presence of microvascular complications in T1D patients.
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Background: PubMed 20950392Borel 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.
- Background: PubMed 22048845Golbidi 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.
- Background: PubMed 25186832Manin 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.
- Background: PubMed 24628249Reutrakul 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.
- Background: PubMed 21679352Schober 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.
- BackgroundTahrani 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abd Tahrani, MD principal investigator
NIHR Clinician Scientist at University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes and Obstructive Sleep Apnoea, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The relationship between OSA and cardiac autonomic neuropathy (CAN) in patients with T1D. (time frame: Single time point measurement (20- 30 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481361, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2020.