The impact of sleep disorders in patients with type 2 diabetes
| ISRCTN | ISRCTN12361838 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12361838 |
| Secondary identifying numbers | 37844 |
- Submission date
- 04/04/2018
- Registration date
- 10/04/2018
- Last edited
- 07/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English Summary
Background and study aims
Type 2 diabetes (T2D) is very common and has a huge burden on patients, carers, and the NHS. Much of the burden of T2D is due to blockages in the small blood vessels, leading to eye, kidney, nerve and foot problems. Around two thirds of patients with T2D also have obstructive sleep apnoea (OSA). OSA is a condition where there are episodes of complete or partial blockage to the windpipe during sleep. This causes a short reduction in breathing. OSA might contribute to small blood vessels disease in T2D, so it is important to examine the impact of OSA treatment on diabetes-related blood vessels disease. The aim of this study is to assess the feasibility of conducting a larger study of the impact of OSA treatment on diabetes-related blood vessels disease. The results could help identify new treatment targets that will reduce the burden of T2D.
Who can participate?
Patients aged 18 and over with T2D
What does the study involve?
Participants undergo a sleep assessment to find out if they have OSA. Those participants with OSA are then be randomly allocated to either receive OSA treatment or not. OSA treatment is called continuous positive airway pressure (CPAP), which is a device that delivers pressure to the upper wind pipes (via a mask worn on the face) to prevent the wind pipes from collapsing during sleep. Participants undergo assessments related to diabetes, diabetes-related complications and sleep disorders at the start and end of the study (after 2 years and also receive 6 monthly phone calls.
What are the possible benefits and risks of participating?
Everyone in the study gets an in-depth check of their diabetes, in much more detail than normal NHS care. Patients with diabetes are not always tested for OSA although it is probably very common. OSA is associated with increased risk of road traffic accidents and increased risk of high blood pressure and heart disease. So, patients participating in this study could benefit from being screened for OSA and may receive treatment. Although there may be no direct benefit to the participants, it is hoped that this study will benefit all patients with type 2 diabetes and OSA in the future. There are no painful procedures in this study, but patients have to visit the study centre. Patients with suspected moderate to severe OSA or those with excessive daytime sleepiness will be referred to the sleep physician who will give advice about whether the patient needs to inform the DVLA (Driver and Vehicle Licencing Agency) after assessing the patient. The DVLA website states that patients must inform the DVLA if the OSA affects the patients’ ability to drive safely or if the patient has daytime sleepiness. If patients are found to have OSA as part of this study, they will be referred to the local NHS sleep clinic. The sleep clinic in the NHS trust will make the final decision regarding the diagnosis of OSA and daytime sleepiness, and will advise patients regarding informing the DVLA. Treatment with CPAP can usually improve sleepiness in most cases and if patients adhere to the CPAP treatment and do not suffer from excessive sleepiness, the DVLA is unlikely to revoke the license because of OSA.
Where is the study run from?
1. St James’s University Hospital (UK)
2. Birmingham Heartlands Hospital (UK)
3. Royal Stoke University Hospital (UK)
4. Queen Elizabeth Hospital (UK)
5. Royal Derby Hospital (UK)
6. York Hospital (UK)
7. Warwick Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2014 to December 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Ryan Ottridge
r.ottridge@bham.ac.uk
Contact information
Scientific
Birmingham Clinical Trials Unit (BCTU)
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0002-8685-2145 |
|---|---|
| Phone | +44 (0)121 415 9125 |
| r.ottridge@bham.ac.uk |
Study information
| Study design | Randomised; Both; Design type: Treatment, Screening, Diagnosis, Prevention, Device, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Participant information sheet can be found at: https://www.birmingham.ac.uk/SleepT2D |
| Scientific title | The impact of sleep disorders in patients with type 2 diabetes: a cohort study and feasibility randomised controlled trial |
| Study acronym | SLEEP T2D |
| Study hypothesis | Type 2 diabetes (T2D) is very common and has a huge burden on patients, carers, and the NHS. Much of the burden of T2D is due to blockages in the small blood vessels leading to eye, kidney, nerve and foot problems. Around two thirds of patients with T2D also have obstructive sleep apnoea (OSA). OSA is a condition where there are episodes of complete or partial blockage to the windpipe during sleep. This causes a short reduction in breathing. Our group showed that OSA might contribute to small blood vessels disease in T2D. Hence, it is important to examine the impact of OSA treatment on diabetes-related blood vessels disease. This study will assess the feasibility of conducting a study assessing the impact of OSA treatment on diabetes-related blood vessels disease. The results could help identify new treatment targets that will reduce the burden of T2D. |
| Ethics approval(s) | Approved 23/05/2018, West Midlands – Solihull (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS UK; solihull.rec@hra.nhs.uk), ref: 18/WM/0070 |
| Condition | Type 2 diabetes mellitus |
| Intervention | The trialists will register up to 500 patients with T2D into a observational cohort study. At baseline all participants will receive a sleep assessment to identify OSA. If they consent to it, those participants with OSA will then be randomised (i.e. allocated treatment by chance like tossing a coin) in a 1:1 ratio to either CPAP or no CPAP. A minimisation algorithm will be used within the computerised randomisation system to ensure balance in the treatment allocation over the following variables: ethnicity, gender, OSA severity. A random element will be included in the minimisation algorithm, so that each patient has a probability of being randomised to the opposite treatment than they would have otherwise received. Full details of the randomisation specification will be stored in a confidential document at BCTU. Continuous positive airway pressure (CPAP is a device that delivers pressure to the upper wind pipes (via a mask worn on the face) to prevent the wind pipes from collapsing during sleep. CPAP will be given for two years. The frequency should be every night, but compliance will be defined as CPAP use of at least 4 hours per night on 70% of nights. Both registered participants and the randomised subset of participants will remain in the study for 2 years. Patients will have clinical assessments related to diabetes, diabetes-related complications and sleep disorders at baseline and at study end (2 years from baseline). Patients will also receive 6 monthly phone calls. |
| Intervention type | Other |
| Primary outcome measure | The feasibility of running a substantive RCT in patients with T2D, randomising participants between CPAP and no CPAP. This decision will be based on the assessment of the data of the primary objectives. The aim of such a substantive RCT would be to determine the impact of OSA treatment (CPAP vs no CPAP) on the progression of diabetic nephropathy/CKD in patients with T2D. The proposed clinical primary outcome would be eGFR as measured by serum creatinine levels. Primary objectives: 1. To assess willingness of participants to be randomised 2. To assess willingness of clinicians to recruit participants 3. To assess follow-up rates and adherence/compliance rates 4. To provide data to inform the sample size for a substantive trial 5. To optimise the choice of outcome measures for a substantive trial This will be compared to the following criteria: 1. Recruiting the proposed sample size within the planned time frames 2. Meeting the proposed time frames in regard to interpreting the sleep assessments and initiating patients on treatment 3. Achieving a follow-up rate ≥80% for randomised patients 4. Achieving a CPAP usage ≥4 hours/night on ≥70% of nights in ≥80% patients randomised to CPAP treatment 5. Generating a mean and standard deviation regarding the predicted response to the intervention to allow sample size calculations for a substantive RCT Timepoint(s): End of the study |
| Secondary outcome measures | Current secondary outcome measures as of 06/08/2020: 1. Diabetic nephropathy and CKD measured using eGFR (ml/min/1.73m2), cystatin-C level (mg/L), and albumin/creatinine ratio (mg/mmol) at baseline and end of follow up (up to 2 years) 2. Diabetic neuropathy measured using peripheral neuropathy: Michigan Neuropathy Screening Instrument, Short Form McGill Pain Questionnaire, vibration perception threshold (present/decreased/absent), monofilament test (normal/reduced/absent); cardiac autonomic neuropathy (normal/borderline/abnormal); and peripheral autonomic neuropathy (normal/borderline/abnormal) at baseline and end of follow up (up to 2 years) 3. Diabetic retinopathy using R grade 0-3 and maculopathy changes using M grade 0-1 at baseline and end of follow up (up to 2 years) 4. Metabolic parameters using weight (kg), HbA1c (mmol/mol), BP (mmHg), and lipids profile (total cholesterol, triglycerides, HDL, LDL; all mmol/L) at baseline and end of follow up (up to 2years) Previous secondary outcome measures: 1. Diabetic nephropathy and CKD measured using eGFR (ml/min/1.73m2), cystatin-C level (mg/L), and albumin/creatinine ratio (mg/mmol) at baseline and 2 years 2. Diabetic neuropathy measured using peripheral neuropathy: Michigan Neuropathy Screening Instrument, Short Form McGill Pain Questionnaire, vibration perception threshold (present/decreased/absent), monofilament test (normal/reduced/absent); cardiac autonomic neuropathy (normal/borderline/abnormal); and peripheral autonomic neuropathy (normal/borderline/abnormal) at baseline and 2 years 3. Diabetic retinopathy using R grade 0-3 and maculopathy changes using M grade 0-1 at baseline and 2 years 4. Metabolic parameters using weight (kg), HbA1c (mmol/mol), BP (mmHg), and lipids profile (total cholesterol, triglycerides, HDL, LDL; all mmol/L) at baseline and 2 years |
| Overall study start date | 01/03/2014 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Total final enrolment | 312 |
| Participant inclusion criteria | Potential participants will be considered eligible for registration into the study if they: 1. Are ≥18 years old 2. Have Type 2 Diabetes 3. Have an eGFR (MDRD-4) ≥15 mL/min/1.73 m2 in last 3 months 4. Have an ESS <11 Potential participants will be considered eligible for randomisation into the RCT if the patient: 1. Is willing to be randomised to CPAP or no CPAP 2. Has a AHI ≥10 |
| Participant exclusion criteria | Potential participants will be excluded from the study if they: 1. Have Type 1 diabetes 2. Have known OSA, active malignancy or chronic kidney disease from reasons other than diabetes 3. Are receiving chemotherapy, immunosuppressant drugs or home oxygen treatment 4. Have a history of recurrent hospital admissions due to infective exacerbation of a respiratory condition 5. Have received contrast imaging within the last two months 6. Are pregnant 7. Are intending to undergo bariatric surgery during the study duration 8. Are unable to comply with the study protocol 9. Are unable to give informed consent 10. Are a professional driver, operator of heavy machinery and/or working at high altitude 11. Have a history of falling asleep whilst driving within last two years After the home-based sleep study, potential participants will be excluded from the RCT if they: 1. Have a resting oxygen saturation < 90% (as detected during the sleep assessment recording) or have central apnoeas > 5/ hour |
| Recruitment start date | 17/08/2018 |
| Recruitment end date | 31/01/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
LS9 7TF
United Kingdom
B9 5ST
United Kingdom
ST4 6QG
United Kingdom
B15 2TH
United Kingdom
DE22 3NE
United Kingdom
YO31 8HE
United Kingdom
CV34 5BW
United Kingdom
Sponsor information
University/education
c/o Dr Sean Jennings
Research Governance
Aston Webb Building
Birmingham
B15 2TT
England
United Kingdom
| Phone | +44 (0)121 414 7618 |
|---|---|
| researchgovernance@contacts.bham.ac.uk | |
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The participant information sheet and protocol will be available at https://www.birmingham.ac.uk/SleepT2D. The protocol will also be published. Results of this trial will be submitted for publication in a peer-reviewed journal. Results will be disseminated to participants by using a participant newsletter, through patient charities, and on the trial website. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/03/2021 | 23/08/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 06/02/2024 | 07/02/2024 | Yes | No |
Editorial Notes
07/02/2024: Publication reference added.
20/03/2023: The following changes were made to the trial record:
1. The total final enrolment was changed from 313 to 312.
2. The intention to publish date was changed from 31/12/2022 to 31/12/2023.
23/08/2022: Publication reference added.
09/11/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 12/02/2020 to 31/01/2020.
2. The overall trial end date was changed from 30/06/2021 to 31/12/2021.
3. The intention to publish date was changed from 31/12/2021 to 31/12/2022.
4. Total final enrolment number added.
06/08/2020: The following changes have been made:
1. The overall trial end date has been changed from 31/12/2020 to 30/06/2021.
2. The recruitment start date has been changed from 01/05/2018 to 17/08/2018.
3. The recruitment end date has been changed from 31/10/2019 to 12/02/2020.
4. The ethics approval has been added.
5. The secondary outcome measures have been updated.
6. The intention to publish date has been changed from 30/04/2021 to 31/12/2021.
7. The plain English summary has been updated to reflect the changes above.
12/05/2020: The following changes have been made:
1. The overall trial end date has been changed from 30/04/2020 to 31/12/2020.
2. The intention to publish date has been changed from 30/04/2020 to 30/04/2021.
3. The plain English summary has been updated to reflect the changes above.
27/03/2019: The condition has been changed from "Specialty: Diabetes, Primary sub-specialty: Type 2; UKCRC code/ Disease: Metabolic and Endocrine/ Diabetes mellitus" to "Type 2 diabetes mellitus" following a request from the NIHR.
