NCT02136615

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. 1.To determine whether the insulin sensitising effect of HBOT is apparent 24-hours after an HBO session.
  2. 2.To examine mechanisms underpinning the increase in insulin sensitivity following HBOT.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

May 2, 2014

Last Update Submit

November 30, 2015

Conditions

Overweight and ObesityInsulin Sensitivity

Keywords

hyperbaric oxygenationinsulin sensitivityhumaninflammationadipose tissue

Outcome Measures

Primary Outcomes (1)

  • Change in insulin sensitivity as measured by FSIGT

    24-hours after the last HBOT

    Baseline, Day 5

Secondary Outcomes (4)

  • Changes in inflammatory markers from blood

    Baseline, Day 2

  • Change in insulin sensitivity by FSIGT

    Baseline, Day 4

  • Changes in inflammatory markers from blood

    Baseline, Day 3

  • Changes in inflammatory markers from blood

    Baseline, Day 5

Other Outcomes (1)

  • Changes in gene expression from adipose tissue

    Baseline, Day 3

Study Arms (1)

overweight and obese male volunteers

BMI between 23-40 kg/m2

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hyperbaric Medicine Unit, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

  • 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.

    PMID: 22269009BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, adipose tissue

MeSH Terms

Conditions

OverweightObesityInsulin ResistanceInflammation

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPathologic Processes

Study Officials

  • Leonie K Heilbronn, PhD

    University of Adelaide, Discipline of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ARC Future Fellow

Study Record Dates

First Submitted

May 2, 2014

First Posted

May 13, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

AU(1)