ObesityHOTAIRNCT01361971
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
A study testing Hyperbaric Oxygen Treatment in people with Obesity and Type 2 Diabetes, run by University of Adelaide at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 45 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes
- What is being tested?
- Hyperbaric Oxygen Treatment
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Obese men with and without type 2 diabetes aged 45-70
- Lean men without type 2 diabetes aged 45-70
Who cannot join
- smokers
- claustrophobic
- sleep apnoea
- blood donor
- exercise more than 2 times per week
- under certain medications eg: bleomycin,corticosteroid
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obesity, Type 2 Diabetes
- Being tested
- Hyperbaric Oxygen Treatment
- Keywords
- Insulin resistance, Inflammation, Hypoxia
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance, Inflammation, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TreatmentProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Using Hyperinsulinemic clamp
Measured: 1 year
Secondary outcomes (1)
Hypoxia and inflammatory markers
using IHC, qPCR, Western blot
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2011 (estimated)
- Study startApr 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A/Prof Leonie Heilbronn, University of Adelaide
- Investigators
- Leonie K Heilbronn, Phd, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361971
- Sponsor's protocol ID
- RAH100615
- Acronym
- HOTAIR
- Status last verified
- Sep 2013
- First submitted
- 24 May 2011
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
- ClinicalTrials.gov ID
- NCT01361971
- Acronym / sponsor ID
- HOTAIR / RAH100615
- Conditions
- Obesity, Type 2 Diabetes
- Keywords
- Insulin resistance, Inflammation, Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 27 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Obese men with and without type 2 diabetes aged 45-70
- Lean men without type 2 diabetes aged 45-70
Key exclusion criteria (6 listed)
- smokers
- claustrophobic
- sleep apnoea
- blood donor
- exercise more than 2 times per week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TreatmentParticipants 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. | Procedure or surgery | – |
Primary outcome
Insulin sensitivity
Time frame: 1 year
Using Hyperinsulinemic clamp
1 secondary outcome
Hypoxia and inflammatory markers
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonie K Heilbronn, Phd principal investigator
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Treatment in people with Obesity and Type 2 Diabetes, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2013.