CPAP and Glucose Metabolism in Non-Diabetic OSA Subjects

Obstructive Sleep Apnea Clinical Trial

Official title:

The Impact of CPAP on Glucose Metabolism in Moderate-Severe Obstructive Sleep Apnoea Patients Without Diabetes - An Observational Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05335083
• Other study ID #: 2021/ETH12082
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: September 2023
• Source: Woolcock Institute of Medical Research
• Contact: David J Sherring, MBBS, DClinD
• Phone: 0407886698
• Email: dshe7670[@]uni.sydney.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the current study is to investigate whether alleviation of OSA by CPAP positively impacts glucose metabolism in non-diabetic patients.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Community dwelling adult males and females aged 18-65 years

2. Polysomnography confirmed moderate to severe OSA with apnea hypopnea index (AHI) =15/hr within the past 60 months

3. Able to give written informed consent

4. Proficient in English

6. Diagnosed non-diabetic as defined by the American Diabetes Association as any of the following recent (<3 months) findings:

1. Fasting glucose with a BGL <7.0 mmol/L

2. Glucose tolerance with a 2-hour BGL of < 11.1 mmol/L after a formal 75g Oral Glucose Tolerance Test (OGTT)

3. HbA1C of = 6.5% 7. Possession or regular access to a mobile telephone with capability to download and run the Withings Sleep Anlayser App.

Exclusion Criteria:

1. Clinically significant co-morbidity (e.g. myocardial infarction, congestive heart failure, stroke, arrythmia, chronic kidney or liver disease, epilepsy, head injury)

2. 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.

3. Regular (>2 times per month) use of sleep-affecting medication (e.g. benzodiazepines, opioids, antidepressants)

4. Regular night shift work or travel overseas within the last 2 weeks

5. Sleep physician has advised against CPAP withdrawal

6. Pregnancy

7. 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

8. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)

9. Current or recent (<3 months) use of hypoglycaemic agents

10. Undergoing a weight loss programme

11. 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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Pre-diabetes
• Prediabetic State
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
A positive CPAP intervention

Locations

Country	Name	City	State
Australia	Woolcock Institute of Medical Research	Macquarie Park	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Woolcock Institute of Medical Research

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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