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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
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
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/NCT02136615