Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance (HOTAIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A/Prof Leonie Heilbronn, University of Adelaide
ClinicalTrials.gov Identifier:
NCT01361971
First received: May 24, 2011
Last updated: September 17, 2013
Last verified: September 2013

May 24, 2011
September 17, 2013
April 2011
January 2013   (final data collection date for primary outcome measure)
Insulin sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Using Hyperinsulinemic clamp
Same as current
Complete list of historical versions of study NCT01361971 on ClinicalTrials.gov Archive Site
Hypoxia and inflammatory markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
using IHC, qPCR, Western blot
Same as current
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Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

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.

Not Provided
Interventional
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Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Obesity
  • Type 2 Diabetes
Procedure: Hyperbaric Oxygen Treatment
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Male
45 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01361971
RAH100615
No
A/Prof Leonie Heilbronn, University of Adelaide
University of Adelaide
Not Provided
Principal Investigator: Leonie K Heilbronn, Phd University of Adelaide
University of Adelaide
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP