Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/04/2018
Date assigned
10/04/2018
Last edited
10/04/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 April 2020

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Ryan Ottridge
r.ottridge@bham.ac.uk

Trial website

https://www.birmingham.ac.uk/SleepT2D

Contact information

Type

Scientific

Primary contact

Mr Ryan Ottridge

ORCID ID

http://orcid.org/0000-0002-8685-2145

Contact details

Birmingham Clinical Trials Unit (BCTU)
Public Health Building
University of Birmingham
Birmingham
B15 2TT
United Kingdom
+44 (0)121 415 9125
r.ottridge@bham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

37844

Study information

Scientific title

The impact of sleep disorders in patients with type 2 diabetes: a cohort study and feasibility randomised controlled trial

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

West Midlands – Solihull, ref: 18/WM/0070 - approval pending

Study design

Randomised; Both; Design type: Treatment, Screening, Diagnosis, Prevention, Device, Cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Participant information sheet can be found at: https://www.birmingham.ac.uk/SleepT2D

Condition

Specialty: Diabetes, Primary sub-specialty: Type 2; UKCRC code/ Disease: Metabolic and Endocrine/ 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

Phase

Drug names

Primary outcome measures

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

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 trial start date

01/03/2014

Overall trial end date

30/04/2020

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 500; UK Sample Size: 500

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

01/05/2018

Recruitment end date

31/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St James’s University Hospital
Beckett Street
LS9 7TF

Trial participating centre

Birmingham Heartlands Hospital
Bordesley Green East
B9 5ST

Trial participating centre

Royal Stoke University Hospital
Newcastle Road
ST4 6QG

Trial participating centre

Queen Elizabeth Hospital
Mindelsohn Way
B15 2TH

Trial participating centre

Royal Derby Hospital
Uttoxeter Road
DE22 3NE

Trial participating centre

York Hospital
Wigginton Road
YO31 8HE

Trial participating centre

Warwick Hospital
Lakin Road
CV34 5BW

Sponsor information

Organisation

University of Birmingham

Sponsor details

c/o Dr Sean Jennings
Research Governance
Aston Webb Building
Birmingham
B15 2TT
United Kingdom
+44 (0)121 414 7618
researchgovernance@contacts.bham.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Trainees Co-ordinating Centre (TCC); Grant Codes: CS-2013-13-029

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

30/04/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes