Trial Review

Please note that the ANZCTR website will be unavailable from 1:00pm until 2:00pm (AEST) on Thursday 10th of April for website maintenance. Please be sure to log out of the system in order to avoid any loss of data. Thank you and apologies for any inconvenience caused.


The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02136615




Registration number
NCT02136615
Ethics application status
Date submitted
2/05/2014
Date registered
13/05/2014
Date last updated
2/12/2015

Titles & IDs
Public title
Does Hyperbaric Oxygen Therapy Lead to a Sustained Increase in Insulin Sensitivity?
Scientific title
Does Hyperbaric Oxygen Therapy Lead to a Sustained Increase in Insulin
Secondary ID [1] 0 0
HREC/14/RAH/118
Universal Trial Number (UTN)
Trial acronym
HOTAIR3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and Obesity 0 0
Insulin Sensitivity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
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
overweight and obese male volunteers - BMI between 23-40 kg/m2
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in insulin sensitivity as measured by FSIGT
Assessment method [1] 0 0
24-hours after the last HBOT
Timepoint [1] 0 0
Baseline, Day 5
Secondary outcome [1] 0 0
Changes in inflammatory markers from blood
Assessment method [1] 0 0
After first HBOT
Timepoint [1] 0 0
Baseline, Day 2
Secondary outcome [2] 0 0
Change in insulin sensitivity by FSIGT
Assessment method [2] 0 0
During third and final HBOT
Timepoint [2] 0 0
Baseline, Day 4
Secondary outcome [3] 0 0
Changes in inflammatory markers from blood
Assessment method [3] 0 0
After second HBOT
Timepoint [3] 0 0
Baseline, Day 3
Secondary outcome [4] 0 0
Changes in inflammatory markers from blood
Assessment method [4] 0 0
24-hours after final HBOT
Timepoint [4] 0 0
Baseline, Day 5

Eligibility
Key inclusion criteria
* Age > 18 (no specific upper age limit)
* All participants will be assessed by a hyperbaric physician to determine fitness to enter the hyperbaric chamber - the standard clinical criteria of the Hyperbaric Medicine Unit will be used
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Personal history of Diabetes or major psychiatric disorders,
* 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 HBOT (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
1/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2015
Sample size
Target
Accrual to date
Final
12
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
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Hyperbaric & Diving Medicine Research Trust
Country [1] 0 0

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, Discipline of Medicine
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 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/NCT02136615