Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01361971




Registration number
NCT01361971
Ethics application status
Date submitted
24/05/2011
Date registered
27/05/2011
Date last updated
19/09/2013

Titles & IDs
Public title
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
Scientific title
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
Secondary ID [1] 0 0
RAH100615
Universal Trial Number (UTN)
Trial acronym
HOTAIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Type 2 Diabetes 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Hyperbaric Oxygen Treatment

Treatment: Surgery: Hyperbaric Oxygen Treatment
Participants will undergo 4 treatments of hyperbaric oxygen. Each treatment consists of 90 minutes compression at 2 atmospheres of pressure, with 30 minutes decompression back to 1 atmosphere, during this time, patients will be treated with 100% Oxygen delivered via a hood system.
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Insulin sensitivity
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Hypoxia and inflammatory markers
Timepoint [1] 0 0
1 year

Eligibility
Key inclusion criteria
* Obese men with and without type 2 diabetes aged 45-70
* Lean men without type 2 diabetes aged 45-70
Minimum age
45 Years
Maximum age
70 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* smokers
* claustrophobic
* sleep apnoea
* blood donor
* exercise more than 2 times per week
* under certain medications eg: bleomycin,corticosteroid

Study design
Purpose of the study
Other
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2013
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
University of Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leonie K Heilbronn, Phd
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01361971