Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance (HOTAIR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A/Prof Leonie Heilbronn, University of Adelaide
ClinicalTrials.gov Identifier:
NCT01361971
First received: May 24, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Obesity
Type 2 Diabetes
Procedure: Hyperbaric Oxygen Treatment

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance

Resource links provided by NLM:


Further study details as provided by University of Adelaide:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Using Hyperinsulinemic clamp


Secondary Outcome Measures:
  • Hypoxia and inflammatory markers [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    using IHC, qPCR, Western blot


Enrollment: 20
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361971

Locations
Australia, South Australia
University of Adelaide
Adelaide, South Australia, Australia
Sponsors and Collaborators
University of Adelaide
Investigators
Principal Investigator: Leonie K Heilbronn, Phd University of Adelaide
  More Information

No publications provided

Responsible Party: A/Prof Leonie Heilbronn, A/Prof, University of Adelaide
ClinicalTrials.gov Identifier: NCT01361971     History of Changes
Other Study ID Numbers: RAH100615
Study First Received: May 24, 2011
Last Updated: September 17, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by University of Adelaide:
Insulin resistance
Inflammation
Hypoxia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Obesity
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014