NCT02009813

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 Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable obesity

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

Study Start

First participant enrolled

March 1, 2013

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

December 9, 2013

Last Update Submit

November 30, 2015

Conditions

ObesityType 2 Diabetes

Keywords

Insulin resistanceInflammationHypoxia

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    2 hours

Secondary Outcomes (1)

  • Hypoxia and inflammatory markers

    2 hours

Interventions

Hyperbaric Oxygen TherapyPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Related Publications (1)

  • Chen M, Liu B, Wilkinson D, Hutchison AT, Thompson CH, Wittert GA, Heilbronn LK. Selenoprotein P is elevated in individuals with obesity, but is not independently associated with insulin resistance. Obes Res Clin Pract. 2017 Mar-Apr;11(2):227-232. doi: 10.1016/j.orcp.2016.07.004. Epub 2016 Aug 11.

    PMID: 27524654DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin ResistanceInflammationHypoxia

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinismPathologic ProcessesSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Study Officials

  • Leonie K Heilbronn, PhD

    University of Adelaide

    PRINCIPAL INVESTIGATOR

  • David Wilkinson, BMBS

    University of Adelaide

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

AU(1)