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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03138746




Registration number
NCT03138746
Ethics application status
Date submitted
1/05/2017
Date registered
3/05/2017
Date last updated
4/11/2020

Titles & IDs
Public title
Insulin Sensitivity During Hyperbaric Oxygen Compared to Hyperbaric Air
Scientific title
Insulin Sensitivity During Hyperbaric Oxygen Compared to Hyperbaric Air
Secondary ID [1] 0 0
R20160801
Universal Trial Number (UTN)
Trial acronym
HOTAIR4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type II 0 0
Insulin Resistance 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes
Inflammatory and Immune System 0 0 0 0
Allergies

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Surgery - HBO
Treatment: Surgery - Hyperbaric air

HBO - On day 2, the participant will undergo a 2-hour hyperbaric exposure breathing 100% oxygen

Hyperbaric air - On day 2, the participant will undergo a 2-hour hyperbaric exposure breathing air


Treatment: Surgery: HBO
Compression in a hyperbaric chamber in air to 2 atmospheres absolute, then donning a "hood" supplying high flow oxygen for 90-minutes followed by a linear decompression back to 1 atmosphere over 30 minutes

Treatment: Surgery: Hyperbaric air
Compression in a hyperbaric chamber in air to 2 atmospheres absolute, then donning a "hood" supplying high flow air for 90-minutes followed by a linear decompression back to 1 atmosphere over 30 minutes
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
insulin sensitivity
Timepoint [1] 0 0
Baseline to Day 2
Secondary outcome [1] 0 0
change in inflammatory cytokines
Timepoint [1] 0 0
Day 1 and 2

Eligibility
Key inclusion criteria
* Men with T2DM, n=40 (numbers are based on power analysis of previous studies)
* Normal to obese weight (BMI 25-40 kg/m2)
* Age > 40 (no specific upper age limit)
* All participants will attend the Hyperbaric Medicine Unit to be assessed by a hyperbaric physician (DW) to determine fitness to enter the hyperbaric chamber the standard clinical criteria of the Hyperbaric Medicine Unit will be used
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* use of prescribed or non-prescribed medications which may affect glucose homeostasis (eg steroids)
* uncontrolled asthma, current fever, upper respiratory infections
* individuals who regularly perform high intensity exercise (>2 week)
* current intake of > 140g alcohol/week
* current smokers of cigarettes/cigars/marijuana
* current intake of any illicit substance
* experience claustrophobia in confined spaces
* has donated blood within past 3-months
* has been involved in any other study within the past 3-months
* unable to comprehend study protocol
* any other contraindication to HBO (eg Eustachian tube dysfunction making middle ear inflation ineffective)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2020
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Hyperbaric Medicine Unit, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Adelaide Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
In a recent series of studies performed by our group, we have shown that exposure to hyperbaric oxygen (HBO) leads to an increase in insulin sensitivity in male subjects with type-2 diabetes (T2DM) and in obese and overweight men without diabetes. The aim of this study is to investigate the relationship between pressure and oxygen in producing this effect, specifically, is this effect measurable in hyperbaric air or is some higher pressure of oxygen required?

Aims:

1. To determine whether the insulin sensitising effect of HBO is apparent in hyperbaric air at the same pressure as HBO.
2. To examine mechanisms underpinning the increase in insulin sensitivity following HBO.
Trial website
https://clinicaltrials.gov/study/NCT03138746
Trial related presentations / publications
Wilkinson D, Chapman IM, Heilbronn LK. Hyperbaric oxygen therapy improves peripheral insulin sensitivity in humans. Diabet Med. 2012 Aug;29(8):986-9. doi: 10.1111/j.1464-5491.2012.03587.x.
Wilkinson D, Nolting M, Mahadi MK, Chapman I, Heilbronn L. Hyperbaric oxygen therapy increases insulin sensitivity in overweight men with and without type 2 diabetes. Diving Hyperb Med. 2015 Mar;45(1):30-6.
Public notes

Contacts
Principal investigator
Name 0 0
David C Wilkinson, FANZCA
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03138746