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Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance (HOTAIR)

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ClinicalTrials.gov Identifier: NCT01361971
Recruitment Status : Completed
First Posted : May 27, 2011
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):
A/Prof Leonie Heilbronn, University of Adelaide

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.

Condition or disease Intervention/treatment Phase
Obesity Type 2 Diabetes Procedure: Hyperbaric Oxygen Treatment Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
Study Start Date : April 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
Drug Information available for: Insulin
U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 1 year ]
    Using Hyperinsulinemic clamp


Secondary Outcome Measures :
  1. Hypoxia and inflammatory markers [ Time Frame: 1 year ]
    using IHC, qPCR, Western blot



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361971


Locations
Australia, South Australia
University of Adelaide
Adelaide, South Australia, Australia
Sponsors and Collaborators
University of Adelaide
Investigators
Principal Investigator: Leonie K Heilbronn, Phd University of Adelaide

Responsible Party: A/Prof Leonie Heilbronn, A/Prof, University of Adelaide
ClinicalTrials.gov Identifier: NCT01361971     History of Changes
Other Study ID Numbers: RAH100615
First Posted: May 27, 2011    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by A/Prof Leonie Heilbronn, University of Adelaide:
Insulin resistance
Inflammation
Hypoxia

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs