CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects
NANOT_YET_RECRUITING
The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.
Study details:
Glucose metabolism in patients newly diagnosed with moderate-severe OSA and without diabetes will be monitored for two weeks prior to commencement of CPAP using a CGM. They will consume a 75g oral glucose drink fasted on waking twice during the two-week monitoring period, having consumed a standardised meal the evening prior. After establishing CPAP use for at least four weeks they will undergo the same protocol as for the observation period prior to commencing CPAP.
Glucose metabolism will be monitored using an interstitial (skin based) glucose monitor.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Community dwelling adult males and females aged 18-65 years
- Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) ≥15/hr within the past 60 months
- Able to give written informed consent
- Proficient in English
- Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (<3 months) findings: Fasting glucose with a BGL <7.0 mmol/L, Glucose tolerance with a 2-hour BGL of < 11.1 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT), HbA1C of ≤ 6.5%
- Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.
Exclusion criteria
- Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury)
- Severe mental health disorders (e.g. current major depressive disorder, schizophrenia, bipolar disorder) that in the opinion of the investigator is not adequately treated or will significantly affect their participation in the study.
- Regular (>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants)
- Regular night shift work or travel overseas within the last 2 weeks
- Sleep physician has advised against CPAP withdrawal
- Pregnancy
- Active smoking or routine alcohol use (more than 2 standard drinks a day) or excessive caffeine intake (>300 mg a day) or recent (in the past month) use of illicit drugs
- Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)
- Current or recent (<3 months) use of hypoglycaemic agents
- Undergoing a weight loss programme
- Contraindications for use of the FreeStyle Libre Pro Sensor. E.g. Known hypersensitivity to skin adhesives such as those used to attach the sensor to the arm.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT05335083
Intervention or treatment
DEVICE: CPAP
Conditions
- Obstructive Sleep Apnea
- Pre-diabetes
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Royal Prince Alfred Hospital
Select from list below to view details:
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, Australia
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Who is running the clinical trial?
WIoMR
Woolcock Institute of Medical Research
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
NO_INTERVENTION: CPAP off condition
| |
EXPERIMENTAL: CPAP on condition
| Device: CPAP |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Mean 24 hour glucose difference between the CPAP on and CPAP off conditions | Average 24 hour glucose difference between CPAP on and CPAP off conditions | 2 weeks |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Mean daytime glucose difference between the CPAP on and CPAP off conditions | Mean Daytime (6:00 AM - 10:00 PM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 weeks |
| Mean night time glucose | Mean Night-time (10:00 PM - 6:00 AM) glucose difference between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 weeks |
| Glucose tolerance | Difference in glucose tolerance as measured by peak 2-hour post 75g glucose load administered twice during each two-week observation period using a CGM | 2 weeks |
| Coefficient of Variation | Percentage CV intraday (i.e. within 24h) and interday (i.e. over multiple days) between the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| SD of Mean Glucose | SD of Mean Glucose (daily) during the CPAP on and CPAP off conditions during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time in Range (TIR) | Percentage of TIR (3.9-10.0 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time Below Range (TBR) | Percentage of TBR (3.9 mmol/L including readings of \<3 .0 mmol/L) during the the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time below Range <3.0 mmol/L | Percentage of TBR \<3.0 mmol/L (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time Above Range (TAR) | Percentage of TAR (\>10.0 mmol/L, including readings \>13.9 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time Above Range >13.9 mmol/L | Percentage of TAR \>13.9 mmol/L (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Time in Tight Range (TITR) | Percentage of TITR (3.9-7.8 mmol/L) (hours and minutes) during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Change in Glucose Management Indicator | Absolute main change in mmol/L or percentage during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Extended hypoglycaemic event rate | Number of events with sensor glucose \<3.9 mmol/L lasting at least 120 min, event ends when glucose returns to at least 3.9 mmol/L for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Extended hyperglycaemic event | Number of events with sensor glucose \>13.9 mmol/L lasting at least 120 min; event ends when glucose returns to 10 mmol/L or less for at least 15 minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TIR >70% | Proportion of participants with TIR 3.9-10.0 mmol/L for \>70% of the day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TIR improvement at least 5% | Proportion of participants with TIR 3.9-10.0 mmol/L with at least a 5% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TIR improvement at least 10% | Proportion of participants with TIR 3.9-10.0 mmol/L with at least a 10% improvement from baseline during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TBR <3.9 mmol/L <4% | Proportion of participants with TBR \<3.9 mmol/L for \<4% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TBR <3.0 mmol/L <1% | Proportion of participants with TBR \<3.0 mmol/L for \<1% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TAR >10.0 mmol/L >25% | Proportion of participants with a TAR \>10.0 mmol/L for \<25% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| TAR >13.9 mmol/L <5% | Proportion of participants with TAR \>13.9 mmol/L for \<5% of each day during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| Hypoglycaemia | Number of times CGM sensor values are \<3.9 mmol/L (including readings of \<3.0 mmol/L) for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol/L. | 2 Weeks |
| Hypoglycaemia Alert Value (Level 1) | Number of times CGM sensor values are 3.0-3.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.9 mmol/L. | 2 Weeks |
| Clinically Significant Hypoglycaemia (Level 2) | Number of times CGM sensor values are \<3.0 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at least 3.0 mmol/L. | 2 Weeks |
| Extended Hypoglycaemia | Number of times CGM sensor values are \<3.9 mmol/L for at least 120 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
| High Glucose Level (Level 1) | Number of times CGM sensor values are 10.1-13.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 10 mmol/L. | 2 Weeks |
| Very High Glucose (Level 2) | Number of times CGM sensor values are \>13.9 mmol/L for at least 15 consecutive minutes during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. The event ends when there is at least 15 consecutive minutes with a CGM sensor value at or below 13.9 mmol/L. | 2 Weeks |
| Extended Hyperglycaemia | Number of times CGM sensor values are \>13.9 mmol/L for at least 90 consecutive minutes within a 120-minute period during the CPAP on and CPAP off conditions as measured by the FreeStyle Libre Pro sensor during the 2-week intervention periods. | 2 Weeks |
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References
Clinical Trials Gov: CPAP and Glucose Metabolism in Non-Diabetic OSA SubjectsOther trials to consider
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