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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/NCT02009813




Registration number
NCT02009813
Ethics application status
Date submitted
9/12/2013
Date registered
12/12/2013
Date last updated
2/12/2015

Titles & IDs
Public title
Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
Scientific title
Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
Secondary ID [1] 0 0
RAH121212a
Universal Trial Number (UTN)
Trial acronym
HOTAIR2
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 Therapy

Treatment: Surgery: Hyperbaric Oxygen Therapy
Participants will undergo 2 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
2 hours
Secondary outcome [1] 0 0
Hypoxia and inflammatory markers
Timepoint [1] 0 0
2 hours

Eligibility
Key inclusion criteria
- Overweight to obese (BMI 25-35 kg/m2)

- Age >18 years (no specific upper age limit)

- Fit to enter hyperbaric chamber as assessed by hyperbaric physician.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Personal history of Diabetes

- Personal history of major psychiatric disorders

- UIse of prescribed or non-prescribed medications which may affect glucose homeostasis
(e.g. steroids),

- Uncontrolled asthma,

- Current fever or upper respiratory infections

- Individuals who regularly perform high intensity exercise (>2 week),

- Pregnancy, lactation and women who are planning to become pregnant

- Current intake of >140g alcohol/week,

- Current smokers of cigarettes/cigars/marijuana,

- Current inatke of any illicit substance,

- Claustrophobia

- has donated blood within past 3 months.

Study design
Purpose of the study
Basic Science
Allocation to intervention
N/A
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
Single group
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
1/03/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - 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 recently shown that exposure to
hyperbaric oxygen (HBO) leads to an increase insulin sensitivity in males ubjects and that
this improvement can be measured in all men, not just those with diabetes. The aim of this
study is to investigate the time course of this effect and explore the mechanisms involved.
The investigators suspect that insulin sensitivity as measured by
hyperinsulinaemic-euglycaemic clamp will be increased within the time-frame of one 2-hour
hyperbaric oxygen exposure, and that the improvement will be measurable in females as well as
males.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02009813
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/NCT02009813