Back to resultsHyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session. (HOTAIR2)
Primary Purpose
Obesity, Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Hyperbaric Oxygen Therapy
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring Insulin resistance, Inflammation, Hypoxia
Eligibility 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.
Sites / Locations
- Royal Adelaide Hospital
Outcomes
Primary Outcome Measures
Insulin sensitivity
Secondary Outcome Measures
Hypoxia and inflammatory markers
Using immuno-histo chemistry (IHC), quantitative plymerase chain reaction (qPCR), Western blot
Full Information
NCT ID
NCT02009813
First Posted
December 9, 2013
Last Updated
November 30, 2015
Sponsor
University of Adelaide
1. Study Identification
Unique Protocol Identification Number
NCT02009813
Brief Title
Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
Acronym
HOTAIR2
Official Title
Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (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 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.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Hyperbaric Oxygen Therapy
Intervention Description
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 Measure Information:
Title
Insulin sensitivity
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Hypoxia and inflammatory markers
Description
Using immuno-histo chemistry (IHC), quantitative plymerase chain reaction (qPCR), Western blot
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie K Heilbronn, PhD
Organizational Affiliation
University of Adelaide
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Wilkinson, BMBS
Organizational Affiliation
University of Adelaide
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
27524654
Citation
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.
Results Reference
derived
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Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.
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