Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

Obesity Clinical Trial

— HOTAIR  

Official title:

Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361971
• Other study ID #: RAH100615
• Status: Completed
• Phase: N/A
• First received: May 24, 2011
• Last updated: September 17, 2013
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2013
• 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Insulin Resistance
• Obesity
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Australia	University of Adelaide	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	Using Hyperinsulinemic clamp	1 year	No
Secondary	Hypoxia and inflammatory markers	using IHC, qPCR, Western blot	1 year	No