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Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance (HOTAIR)

Primary Purpose

Obesity, Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Hyperbaric Oxygen Treatment
Sponsored by
University of Adelaide
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring Insulin resistance, Inflammation, Hypoxia

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Obese men with and without type 2 diabetes aged 45-70
  • Lean men without type 2 diabetes aged 45-70

Exclusion Criteria:

  • smokers
  • claustrophobic
  • sleep apnoea
  • blood donor
  • exercise more than 2 times per week
  • under certain medications eg: bleomycin,corticosteroid

Sites / Locations

  • University of Adelaide

Outcomes

Primary Outcome Measures

Insulin sensitivity
Using Hyperinsulinemic clamp

Secondary Outcome Measures

Hypoxia and inflammatory markers
using IHC, qPCR, Western blot

Full Information

First Posted
May 24, 2011
Last Updated
September 17, 2013
Sponsor
University of Adelaide
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1. Study Identification

Unique Protocol Identification Number
NCT01361971
Brief Title
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
Acronym
HOTAIR
Official Title
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Adelaide

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 preliminary evidence showing that hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires confirmation in a larger population, and with this study the investigators will also test for mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress response proteins following changes in tissue oxygenation may contribute to these improvements. This study has the potential to yield new and important insights into the insulin resistance in obesity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Type 2 Diabetes
Keywords
Insulin resistance, Inflammation, Hypoxia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Treatment
Intervention Description
Participants will undergo 4 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.
Primary Outcome Measure Information:
Title
Insulin sensitivity
Description
Using Hyperinsulinemic clamp
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Hypoxia and inflammatory markers
Description
using IHC, qPCR, Western blot
Time Frame
1 year

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Obese men with and without type 2 diabetes aged 45-70 Lean men without type 2 diabetes aged 45-70 Exclusion Criteria: smokers claustrophobic sleep apnoea blood donor exercise more than 2 times per week under certain medications eg: bleomycin,corticosteroid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie K Heilbronn, Phd
Organizational Affiliation
University of Adelaide
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Adelaide
City
Adelaide
State/Province
South Australia
Country
Australia

12. IPD Sharing Statement

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