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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Basic Science
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
Not Applicable
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
Obesity is an epidemic in Western society and is the biggest risk factor for insulin
resistance and type 2 diabetes. The investigators have preliminary evidence showing that
hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires
confirmation in a larger population, and with this study the investigators will also test for
mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress
response proteins following changes in tissue oxygenation may contribute to these
improvements. This study has the potential to yield new and important insights into the
insulin resistance in obesity.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01361971
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01361971