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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
Timepoint [1] 0 0
Baseline, Day 5
Secondary outcome [1] 0 0
Changes in inflammatory markers from blood
Timepoint [1] 0 0
Baseline, Day 2
Secondary outcome [2] 0 0
Change in insulin sensitivity by FSIGT
Timepoint [2] 0 0
Baseline, Day 4
Secondary outcome [3] 0 0
Changes in inflammatory markers from blood
Timepoint [3] 0 0
Baseline, Day 3
Secondary outcome [4] 0 0
Changes in inflammatory markers from blood
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Hyperbaric & Diving Medicine Research Trust
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 (HBOT) leads to an increase in insulin sensitivity in male subjects 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 when exposure to HBOT induces an increase in peripheral insulin sensitivity.

Aims:

1. To determine whether the insulin sensitising effect of HBOT is apparent 24-hours after an HBO session.
2. To examine mechanisms underpinning the increase in insulin sensitivity following HBOT.
Trial website
https://clinicaltrials.gov/study/NCT02136615
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.
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
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/NCT02136615