Overweight and ObesityHOTAIR3NCT02136615
Does Hyperbaric Oxygen Therapy Lead to a Sustained Increase in Insulin Sensitivity?
An observational study of Overweight and Obesity and Insulin Sensitivity, run by University of Adelaide at 1 site in Australia.
Trial summary
In a recent series of studies performed by our group, we have shown that exposure to hyperbaric oxygen (HBOT) leads to an increase in insulin sensitivity in male subjects and that this improvement can be measured in all men, not just those with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Insulin Sensitivity
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2014to Oct 2015
- Phase
- Observational
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Age > 18 (no specific upper age limit)
- All participants will be assessed by a hyperbaric physician to determine fitness to enter the hyperbaric chamber - the standard clinical criteria of the Hyperbaric Medicine Unit will be used
Who cannot join
- Personal history of Diabetes or major psychiatric disorders,
- use of prescribed or non-prescribed medications which may affect glucose homeostasis (eg steroids)
- uncontrolled asthma, current fever, upper respiratory infections
- individuals who regularly perform high intensity exercise (>2 week)
- current intake of > 140g alcohol/week
- current smokers of cigarettes/cigars/marijuana
Show all 12Show fewer
- current intake of any illicit substance
- experience claustrophobia in confined spaces
- has donated blood within past 3-months
- has been involved in any other study within the past 3-months
- unable to comprehend study protocol
- any other contraindication to HBOT (eg Eustachian tube dysfunction making middle ear inflation ineffective)
Trial locations and contacts
1 site in 1 country.
Australia1 site
Hyperbaric Medicine Unit, Royal Adelaide Hospital
Adelaide, South Australia, 5000
About this study
Official title: Does Hyperbaric Oxygen Therapy Lead to a Sustained Increase in Insulin
In a recent series of studies performed by our group, we have shown that exposure to hyperbaric oxygen (HBOT) leads to an increase in insulin sensitivity in male subjects 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 when exposure to HBOT induces an increase in peripheral insulin sensitivity.
Aims:
- To determine whether the insulin sensitising effect of HBOT is apparent 24-hours after an HBO session.
- To examine mechanisms underpinning the increase in insulin sensitivity following HBOT.
Read the detailed description
All participants will attend the Hyperbaric Medicine Unit on 5 occasions. Day 1 will be for baseline assessment. Days 2 to 5 will be on consecutive days the following week. An overnight fast will be required prior to each day.
Day 1. Baseline assessment. The participant will attend after an overnight fast at 0830 for frequently sampled intravenous glucose tolerance test (FSIGT). Two IV lines will be placed and baseline blood samples (30ml) are drawn for measurement of gluco-regulatory hormones and metabolites at time 0. A glucose bolus is then administered through the antecubital vein IV (300mg/kg, 25% Dextrose infused over 1-minute) at time 0. Blood sampling (3ml) is then performed at 2,4,6,8,10,12,14,16,19,22,25,30,40,50,60,70,90,120,150,180 minutes after the completion of the glucose bolus. Each blood sample is analysed for glucose and insulin. Total blood collected during this procedure is approximately 60mls. A urine sample will be collected. A meal will be provided.
Day 2. The following week, the participant will attend at 0800 after an overnight fast. They will then be placed supine on a bed and a subcutaneous adipose tissue biopsy will be performed using the technique of Bergstrom: after cleansing the skin on the abdomen lateral to the umbilicus with chlorhexidine solution, and placing a fenestrated drape, anaesthesia is administered (5mL of Xylocaine 2%, no adrenaline). A 7.5mm incision is made in the skin (#11 scalpel) and a 5mm Bergstrom needle inserted to collect approximately 250mg of adipose tissue with suction. Two or three passes will be used to obtain approximately 500mg of adipose tissue. The sample is washed in sterile phosphate buffer solution and snap frozen in liquid nitrogen. Upon completion of the biopsy the incision is closed with a sterile bandage, a sterile dressing applied and pressure is applied for 10-minutes. Blood will be taken for glucose, insulin and inflammatory markers (30mls). The participant will then sit in a chair for 2-hours during a routine HBOT session from 0830-1030 (10:90:30 profile). After the first HBOT, a further blood sample will be taken for inflammatory markers. Food will be provided.
Day 3. After an overnight fast, the participant will undergo a second routine HBOT session from 0830-1030, followed by a second fat tissue biopsy. Blood will be taken for glucose, insulin and inflammatory markers (30mls) before and after the HBOT. Food will be provided.
Day 4. After an overnight fast, the participant will undergo a third HBOT session from 0830-1030. This will be undertaken simultaneously with a FSIGT. The IV glucose bolus will be administered at the beginning of the HBOT once the hyperbaric chamber has reached treatment pressure (2 atmospheres absolute). On completion of the FSIGT, a meal will be provided.
Day 5. After an overnight fast, the participant will attend at 0830 for a fourth blood sample for inflammatory markers. An FSIGT will be performed in room air outside the hyperbaric chamber. A meal will be provided. A urine sample will be collected.
With blood taken during three FSIGTs together with 5 blood samples taken for inflammatory markers, a total of about 330 mls of blood will be drawn over 9 days.
- Conditions
- Overweight and Obesity, Insulin Sensitivity
- Keywords
- hyperbaric oxygenation, insulin sensitivity, human, inflammation, adipose tissue
- Medical subject headings
- Overweight, Obesity, Insulin Resistance, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| overweight and obese male volunteers | BMI between 23-40 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in insulin sensitivity as measured by FSIGT
24-hours after the last HBOT
Measured: Baseline, Day 5
Secondary outcomes (4)
Changes in inflammatory markers from blood
After first HBOT
Measured: Baseline, Day 2
Change in insulin sensitivity by FSIGT
During third and final HBOT
Measured: Baseline, Day 4
Changes in inflammatory markers from blood
After second HBOT
Measured: Baseline, Day 3
Changes in inflammatory markers from blood
24-hours after final HBOT
Measured: Baseline, Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Hyperbaric & Diving Medicine Research Trust
- Responsible party
- Principal investigator, A/Prof Leonie Heilbronn, University of Adelaide
- Investigators
- Leonie K Heilbronn, PhD, Principal investigator, University of Adelaide, Discipline of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136615
- Sponsor's protocol ID
- HREC/14/RAH/118
- Acronym
- HOTAIR3
- Status last verified
- Nov 2015
- First submitted
- 2 May 2014
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wilkinson D, Chapman IM, Heilbronn LK. Hyperbaric oxygen therapy improves peripheral insulin sensitivity in humans. Diabet Med. 2012 Aug;29(8):986-9. doi: 10.1111/j.1464-5491.2012.03587.x.
PubMed 22269009
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Hyperbaric Oxygen Therapy Lead to a Sustained Increase in Insulin
- ClinicalTrials.gov ID
- NCT02136615
- Acronym / sponsor ID
- HOTAIR3 / HREC/14/RAH/118
- Conditions
- Overweight and Obesity, Insulin Sensitivity
- Keywords
- hyperbaric oxygenation, insulin sensitivity, human, inflammation, adipose tissue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Collaborators
- Australasian Hyperbaric & Diving Medicine Research Trust
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 May 2014 (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.
In a recent series of studies performed by our group, we have shown that exposure to hyperbaric oxygen (HBOT) leads to an increase in insulin sensitivity in male subjects 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 when exposure to HBOT induces an increase in peripheral insulin sensitivity.
Aims:
- To determine whether the insulin sensitising effect of HBOT is apparent 24-hours after an HBO session.
- To examine mechanisms underpinning the increase in insulin sensitivity following HBOT.
Detailed description
All participants will attend the Hyperbaric Medicine Unit on 5 occasions. Day 1 will be for baseline assessment. Days 2 to 5 will be on consecutive days the following week. An overnight fast will be required prior to each day.
Day 1. Baseline assessment. The participant will attend after an overnight fast at 0830 for frequently sampled intravenous glucose tolerance test (FSIGT). Two IV lines will be placed and baseline blood samples (30ml) are drawn for measurement of gluco-regulatory hormones and metabolites at time 0. A glucose bolus is then administered through the antecubital vein IV (300mg/kg, 25% Dextrose infused over 1-minute) at time 0. Blood sampling (3ml) is then performed at 2,4,6,8,10,12,14,16,19,22,25,30,40,50,60,70,90,120,150,180 minutes after the completion of the glucose bolus. Each blood sample is analysed for glucose and insulin. Total blood collected during this procedure is approximately 60mls. A urine sample will be collected. A meal will be provided.
Day 2. The following week, the participant will attend at 0800 after an overnight fast. They will then be placed supine on a bed and a subcutaneous adipose tissue biopsy will be performed using the technique of Bergstrom: after cleansing the skin on the abdomen lateral to the umbilicus with chlorhexidine solution, and placing a fenestrated drape, anaesthesia is administered (5mL of Xylocaine 2%, no adrenaline). A 7.5mm incision is made in the skin (#11 scalpel) and a 5mm Bergstrom needle inserted to collect approximately 250mg of adipose tissue with suction. Two or three passes will be used to obtain approximately 500mg of adipose tissue. The sample is washed in sterile phosphate buffer solution and snap frozen in liquid nitrogen. Upon completion of the biopsy the incision is closed with a sterile bandage, a sterile dressing applied and pressure is applied for 10-minutes. Blood will be taken for glucose, insulin and inflammatory markers (30mls). The participant will then sit in a chair for 2-hours during a routine HBOT session from 0830-1030 (10:90:30 profile). After the first HBOT, a further blood sample will be taken for inflammatory markers. Food will be provided.
Day 3. After an overnight fast, the participant will undergo a second routine HBOT session from 0830-1030, followed by a second fat tissue biopsy. Blood will be taken for glucose, insulin and inflammatory markers (30mls) before and after the HBOT. Food will be provided.
Day 4. After an overnight fast, the participant will undergo a third HBOT session from 0830-1030. This will be undertaken simultaneously with a FSIGT. The IV glucose bolus will be administered at the beginning of the HBOT once the hyperbaric chamber has reached treatment pressure (2 atmospheres absolute). On completion of the FSIGT, a meal will be provided.
Day 5. After an overnight fast, the participant will attend at 0830 for a fourth blood sample for inflammatory markers. An FSIGT will be performed in room air outside the hyperbaric chamber. A meal will be provided. A urine sample will be collected.
With blood taken during three FSIGTs together with 5 blood samples taken for inflammatory markers, a total of about 330 mls of blood will be drawn over 9 days.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| overweight and obese male volunteers | – | –BMI between 23-40 kg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (2 listed)
- Age > 18 (no specific upper age limit)
- All participants will be assessed by a hyperbaric physician to determine fitness to enter the hyperbaric chamber - the standard clinical criteria of the Hyperbaric Medicine Unit will be used
Key exclusion criteria (12 listed)
- Personal history of Diabetes or major psychiatric disorders,
- use of prescribed or non-prescribed medications which may affect glucose homeostasis (eg steroids)
- uncontrolled asthma, current fever, upper respiratory infections
- individuals who regularly perform high intensity exercise (>2 week)
- current intake of > 140g alcohol/week
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in insulin sensitivity as measured by FSIGT
Time frame: Baseline, Day 5
24-hours after the last HBOT
4 secondary outcomes
Changes in inflammatory markers from blood
Time frame: Baseline, Day 2
Change in insulin sensitivity by FSIGT
Time frame: Baseline, Day 4
Changes in inflammatory markers from blood
Time frame: Baseline, Day 3
Changes in inflammatory markers from blood
Time frame: Baseline, Day 5
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 2 Dec 2015.
- Background: PubMed 22269009Wilkinson D, Chapman IM, Heilbronn LK. Hyperbaric oxygen therapy improves peripheral insulin sensitivity in humans. Diabet Med. 2012 Aug;29(8):986-9. doi: 10.1111/j.1464-5491.2012.03587.x.
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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, Discipline of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity and Insulin Sensitivity, 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 12 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 2 Dec 2015. 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?
Change in insulin sensitivity as measured by FSIGT (time frame: Baseline, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02136615, which also lists 1 linked publication.
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 2 Dec 2015.