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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02009813
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : December 2, 2015
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 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
Study Start Date : March 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy


Intervention Details:
  • Procedure: 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.


Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 2 hours ]

Secondary Outcome Measures :
  1. Hypoxia and inflammatory markers [ Time Frame: 2 hours ]
    Using immuno-histo chemistry (IHC), quantitative plymerase chain reaction (qPCR), Western blot



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02009813


Locations
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Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
University of Adelaide
Investigators
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Principal Investigator: Leonie K Heilbronn, PhD University of Adelaide
Principal Investigator: David Wilkinson, BMBS University of Adelaide
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: A/Prof Leonie Heilbronn, A/Prof, University of Adelaide
ClinicalTrials.gov Identifier: NCT02009813    
Other Study ID Numbers: RAH121212a
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by A/Prof Leonie Heilbronn, University of Adelaide:
Insulin resistance
Inflammation
Hypoxia
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases