Hyperbaric Oxygen Therapy and Insulin Resistance.

Not Applicable

Recruiting

• Conditions: Insulin sensitivity; Metabolic and Endocrine - Diabetes; Diet and Nutrition - Obesity

• Registration Number: ACTRN12613000434796
• Lead Sponsor: David Wilkinson

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Overweight and obesity (BMI 25-35kg/m2)
2. Assessed fitness to enter hyperbaric chamber

Exclusion Criteria

1. Personal history of Diabetes or major psychiatric disorders,
2. Use of prescribed or non-prescribed medications which may affect glucose homeostasis (eg steroids)
3. Uncontrolled asthma, current fever, upper respiratory infections
4. Individuals who regularly perform high intensity exercise (>2 week)
5. Pregnancy, lactation (breast feeding), women who are planning to become pregnant.
6. Current intake of > 140g alcohol/week
7. Current smokers of cigarettes/cigars/marijuana
8. Current intake of any illicit substance
9. Experience claustrophobia in confined spaces
10. Has donated blood within past 3-months
11. Has been involved in any other study within the past 3-months
12. Unable to comprehend study protocol
13. Any other contraindication to HBOT (eg Eustachian tube dysfunction making middle ear inflation ineffective)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin sensitivity, as measured by the hyperinsulinaemic euglycaemic clamp.[The clamps will be used to measure insulin sensitivity on two separate days. The first clamp will occur without hyperbaric oxygen (HBO) treatment, and act as a 'basline' measurement, while the second clamp will occur the following day with a 2-hour HBO treatment starting after the first hour. ];Inflammation and angiogenesis associated with insulin resistance, as measured by levels of various cytokine markers (CRP, MCP1, TNFa, IL-6, ICAM-1, VEGFa and PDGF) using various serum and plasma assays.[At t=0min, 60min and 120min of a 2 hour period with or without hyperbaric oxygen exposure.]

Secondary Outcome Measures

Name	Time	Method
Gene expression related to inflammation and angiogenesis present in adipose tissue samples will be measured using Q-PCR.[At baseline, and after one 2-hour hyperbaric oxygen exposure.]