ObesityNCT01472328
Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
A study testing HBO therapy and Hyperbaric room air in people with Obesity and Non-insulin-dependent Diabetes Mellitus, run by German Diabetes Center at 1 site in Germany.
Trial summary
Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Non-insulin-dependent Diabetes Mellitus
- What is being tested?
- HBO therapy and Hyperbaric room air
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2012to Aug 2015
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged ≥ 30 years- ≤ 70 years
- Balanced sex (50: 50)
- BMI 20- 25 kg/m 2 normal- weight group
- BMI 35- 39,9 kg/m 2 (Obese typ II)
Who cannot join
- Acute illness 2 weeks before start of examination
- Autoimmune or Immune disorder deseases (Leukozyten < 5000/µl
- Renal insufficiency (Kreatin > 1,5 mg/dl)
- Heart disease, condition after heart attack
- Anemia (Hb <12g/l, contolled before every day of eximination) or blood donations 4weeks before eximinatin.
- Participation in another trial within the last 2 weeks
Show all 18Show fewer
- Pharmacological- immuno therapy (Cortisol, Antihistaminika, ASS)
- Thyroid disorders
- Glitazone or Insulin- Therapy
- Pragnancy, Lactation, Menstruation
- Smoking cigaretts, Alcohol- and drug abuse
- Psychiatric disorders
- Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C
- Liver disease, which are not caused by non- alcoholic steato- hepatitis
- Working on night shifts or irregular rhythem of night- day
- Impaired wound healing or clotting disorders
- Allergic reaction to local anesthetics
- Malignant cancer
Trial locations and contacts
1 site in 1 country.
About this study
Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients.
Read the detailed description
HBO therapy is applied to improve wound healing in diabetic patients with foot ulcera. However, it might induce oxidative stress as well as improve antioxidative capacity. The effects on insulin sensitivity in humans and will be tested in the study.
- Conditions
- Obesity, Non-insulin-dependent Diabetes Mellitus
- Being tested
- HBO therapy, Hyperbaric room air
- Keywords
- Oxidative stress, Insulin resistance
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBO therapyProcedure or surgery
Also called oxidative stress, antioxidative capacity
Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Hyperbaric room airProcedure or surgery
Also called HBO therapy, oxidative stress
Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus Receives: Procedure: HBO therapy |
| Hyperbaric room air | Sham comparator | Effect of 2 hrs hyperbaric room air herapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus Receives: Procedure: Hyperbaric room air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle insulin sensitivity
Determination of the influence of 2 hours hyperoxygenation on insulin sensitivity redox balance and lipid metabolites of skeletal muscle in patients with T2DM
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startMar 2012
- Primary completionMar 2015
- Study completionAug 2015
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Responsible party
- Sponsor
- Investigators
- Michael Roden, Prof., MD, Principal investigator, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472328
- Sponsor's protocol ID
- ROS Paradoxon
- Status last verified
- Jun 2023
- First submitted
- 13 Nov 2011
- Last updated
- 13 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT01472328
- Acronym / sponsor ID
- ROS Paradoxon
- Conditions
- Obesity, Non-insulin-dependent Diabetes Mellitus
- Keywords
- Oxidative stress, Insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Study start
- Mar 2012 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Nov 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.
Hyperbaric oxygen therapy (HBO) is applied for several diseases. The effect on insulin sensitivity is yet unknown. Hypothesis: HBO therapy improves insulin sensitivity in patients.
Detailed description
HBO therapy is applied to improve wound healing in diabetic patients with foot ulcera. However, it might induce oxidative stress as well as improve antioxidative capacity. The effects on insulin sensitivity in humans and will be tested in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygen therapy | Experimental | Procedure: HBO therapyEffect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus |
| Hyperbaric room air | Sham comparator | Procedure: Hyperbaric room airEffect of 2 hrs hyperbaric room air herapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged ≥ 30 years- ≤ 70 years
- Balanced sex (50: 50)
- BMI 20- 25 kg/m 2 normal- weight group
- BMI 35- 39,9 kg/m 2 (Obese typ II)
Key exclusion criteria (18 listed)
- Acute illness 2 weeks before start of examination
- Autoimmune or Immune disorder deseases (Leukozyten < 5000/µl
- Renal insufficiency (Kreatin > 1,5 mg/dl)
- Heart disease, condition after heart attack
- Anemia (Hb <12g/l, contolled before every day of eximination) or blood donations 4weeks before eximinatin.
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 |
|---|---|---|
| HBO therapyAlso: oxidative stress, antioxidative capacityEffect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus | Procedure or surgery | Hyperbaric oxygen therapy |
| Hyperbaric room airAlso: HBO therapy, oxidative stressEffect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus | Procedure or surgery | Hyperbaric room air |
Primary outcome
Skeletal muscle insulin sensitivity
Time frame: 2 years
Determination of the influence of 2 hours hyperoxygenation on insulin sensitivity redox balance and lipid metabolites of skeletal muscle in patients with T2DM
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 13 Jun 2023.
- HomepageLink provided by the sponsor.
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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.
Michael Roden, Prof., MD principal investigator
German Diabetes Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBO therapy and Hyperbaric room air in people with Obesity and Non-insulin-dependent Diabetes Mellitus, run by German Diabetes Center at 1 site in Germany.
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 4 inclusion and 18 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 13 Jun 2023. 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 Germany. 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. Some participants in this study may receive a placebo. 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?
Skeletal muscle insulin sensitivity (time frame: 2 years). 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 13 Jun 2023.