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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

Tracking Information
First Submitted Date  ICMJE December 9, 2013
First Posted Date  ICMJE December 12, 2013
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE March 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2013)		 Insulin sensitivity [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2013)		 Hypoxia and inflammatory markers [ Time Frame: 2 hours ]
Using immuno-histo chemistry (IHC), quantitative plymerase chain reaction (qPCR), Western blot
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
Official Title  ICMJE Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Obesity
  • Type 2 Diabetes
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2015)		 9
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2013)		 20
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02009813
Other Study ID Numbers  ICMJE RAH121212a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party A/Prof Leonie Heilbronn, University of Adelaide
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Adelaide
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Leonie K Heilbronn, PhD University of Adelaide
Principal Investigator: David Wilkinson, BMBS University of Adelaide
PRS Account University of Adelaide
Verification Date November 2015

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