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

Obesity Clinical Trial

— HOTAIR2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02009813
• Other study ID #: RAH121212a
• Status: Completed
• Phase: N/A
• First received: December 9, 2013
• Last updated: November 30, 2015
• Start date: March 2013
• Est. completion date: March 2014

Study information

• Verified date: November 2015
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		2 hours	No
Secondary	Hypoxia and inflammatory markers	Using immuno-histo chemistry (IHC), quantitative plymerase chain reaction (qPCR), Western blot	2 hours	No