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Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.

NCT ID: NCT02009813

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Type 2 Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Hyperbaric Oxygen Therapy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Adelaide

OTHER

Sponsor Role lead

Responsible Party

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A/Prof Leonie Heilbronn

A/Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leonie K Heilbronn, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide

David Wilkinson, BMBS

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide

Locations

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Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 27524654 (View on PubMed)

Other Identifiers

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RAH121212a

Identifier Type: -

Identifier Source: org_study_id