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Completed

NCT Number: NCT02009813

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperbaric Oxygen Therapy

Procedure

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 outcomes

  1. Insulin sensitivity

    Time frame: 2 hours

Secondary outcomes

  1. Hypoxia and inflammatory markers

    Time frame: 2 hours

    Using immuno-histo chemistry (IHC), quantitative plymerase chain reaction (qPCR), Western blot

Sponsors and collaborators

Lead sponsor

University of Adelaide

Other

Registry information

Acronym: HOTAIR2

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2013
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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