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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Adelaide
Sponsor:
Information provided by (Responsible Party):
A/Prof Leonie Heilbronn, University of Adelaide
ClinicalTrials.gov Identifier:
NCT02009813
First received: December 9, 2013
Last updated: June 16, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Obesity
Type 2 Diabetes
Procedure: Hyperbaric Oxygen Therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Hyperbaric Oxygen Therapy and Insulin Resistance (HOTAIR2) - Effect of One HBO Session.

Resource links provided by NLM:


Further study details as provided by University of Adelaide:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hypoxia and inflammatory markers [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Using immuno-histo chemistry (IHC), quantitative plymerase chain reaction (qPCR), Western blot


Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  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: NCT02009813

Contacts
Contact: Briohny A Johnston, BSc (Hons) +61 08 8313 6278 briohny.johnston@adelaide.edu.au
Contact: Leonie K Heilbronn, PhD +61 08 8222 4900 leonie.heilbronn@adelaide.edu.au

Locations
Australia, South Australia
Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
University of Adelaide
Investigators
Principal Investigator: Leonie K Heilbronn, PhD University of Adelaide
Principal Investigator: David Wilkinson, BMBS University of Adelaide
  More Information

No publications provided

Responsible Party: A/Prof Leonie Heilbronn, A/Prof, University of Adelaide
ClinicalTrials.gov Identifier: NCT02009813     History of Changes
Other Study ID Numbers: RAH121212a
Study First Received: December 9, 2013
Last Updated: June 16, 2014
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
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Insulin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014