Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
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 pa
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 5/ hour
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Outcome results
None listed