Health effects of treating sleep apnoea with Continuous Positive Airway Pressure (CPAP) during weight loss in people with pre-diabetes, sleep apnoea and obesity.

Not Applicable

Completed

• Conditions: Metabolic and Endocrine - Diabetes; Obstructive sleep apnoea; Pre-diabetes; obesity; Respiratory - Sleep apnoea; Diet and Nutrition - Obesity

• Registration Number: ACTRN12617000823370
• Lead Sponsor: Woolcock Institute of Medical Research, University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-06
• Study Completion: 2020-03-05
• Last Update Posted: 22 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

1. Community dwelling adults aged 18-65 years
2. Waist circumference: females >88cm, males >102cm
non-European: famales >80cm, males >90cm
and/or BMI >=27kg/m2
3. Pre-diabetes defined per World Health Organisation as any of the following recent (<3 months) findings:
a) impaired fasting glucose with BGL between 5.5 and 7.0 mmol/L;
b) impaired glucose tolerance with BGL between 7.8 and 11.0 mmol/L after a formal 75g OGTT;
c) HbA1C between 6 and 6.5%
4. Moderate-severe hypoxaemic OSA with AHI>=20/hr and ODI>=10/hr prior to VLED induced weight loss, based on recent (<12 months) polysomography

Exclusion Criteria

1. Any known contraindications to VLED or exercise
2. Recent weight loss that in the opinion of the treating physician is clinically significant
3. Current or recent (<3months) treatment of OSA
4. Professional drivers who are sleepy
5. Recent (<6 month) history of fall-asleep car crashes or near miss accidents
6. Excessive sleepiness that in the opinion of the treating physician requires immediate CPAP treatment
7. Severe medical (including renal failure) or psychiatric co-morbidity
8. Unstable medical conditions (hypertension, cardiac)
9. Recent use of illicit drugs or alcohol dependence
10. Current (or recent <3 months) use of hypoglycaemic agents
11. Current or previous diagnosis of diabetes mellitus (previous gestational diabetes mellitus not excluded)
12. Respiratory failure including obesity hypoventilation syndrome (OHS) (OHS as diagnosed by physician, based on standard criteria including: BMI >30kg/m2, arterial PaCO2 >45 and evidence of prolonged periods of hypoventilation and hypoxemia during sleep)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose tolerance, as measured by two hour blood glucose level following an oral glucose tolerance test[Measured at Baseline, 3 months primary end point and at 12 months]