Type 2-diabetesNCT04219215
Acute Hyperbaric Oxygen Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in T2D
A study testing 100% O2 in oxygen chamber and 21% O2 in oxygen chamber in people with Type 2-diabetes, run by German Diabetes Center at 1 site in Germany.
Trial summary
Diabetes mellitus type 2 (T2D) is characterized by insulin resistance of liver and skeletal muscle, which is at least partly due to impaired muscle mitochondrial function. Long-term HBO therapy, as applied for treating the diabetic foot syndrome, has been shown to improve blood glucose concentrations. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Type 2-diabetes
- What is being tested?
- 100% O2 in oxygen chamber and 21% O2 in oxygen chamber
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2020to 20 Sep 2022
- 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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years
- Type 2 diabetes
- HbA1c ≥ 6 and ≤ 9%
- BMI ≤ 35 kg / m2
Who cannot join
- Treatment with thiazolidinedione in the last 6 months
- Uncontrolled hyperglycemia (FPG ≥ 240 mg / dl)
- vitamin supplement (washing out at least 4 weeks)
- Patients requiring revascularization
- Serum CRP ≥ 5 mg / dl
- Previous treatment for HBO therapy
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- Secondary diabets according to ADA criteria (type 3 B-H, eg pancreopriver diabetes)
- Type 4 diabetes (gestational diabetes), pregnancy
- poor glycemic control (HbA1c> 9.0%)
- Hyperlipidemia (low density triglycerides and lipoproteins ≥ double upper Reference limit)
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Acute Hyperbaric Oxygen (HBO) Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in Type 2 Diabetes
Diabetes mellitus type 2 (T2D) is characterized by insulin resistance of liver and skeletal muscle, which is at least partly due to impaired muscle mitochondrial function. Long-term HBO therapy, as applied for treating the diabetic foot syndrome, has been shown to improve blood glucose concentrations. To study the underlying mechanisms, we want to examin the short-term effect of HBO treatment on insulin sensitivity and mitochondrial oxidative capacity and production of reactive oxygen species (ROS) in a randomized, double blinded, placebo-controlled cross-over trial.
Read the detailed description
In total 14 patients are planned. Each participant participates in both experimental parts (100% O2 and ambient air). They are examined immediately after each HBO/ ambient air therapy. The allocation is randomized treated every three weeks with 2-hour therapies using pure O2 or indoor air. Randomized and double-blinded in a cross-over setting, one group of patients with type 2 diabetes is first treated with HBO therapy and the other group is first treated with room air. Here, an ambient pressure of 2.4 ATM is built up and then administered for respiration over a total of 90 minutes of pure O2. Patients are examined on two consecutive days for each part of the study.On the first day serum samples are taken and a sample is taken from the vastus lateralis muscle. A magnetic resonance spectroscopic examination (MRS) is performed on the patient subsequently. In this case, phosphorus metabolites (absolute quantification of ATP, Pi) and the ATP synthase flow rate (fATP) are determined non-invasively by means of 31P MRS and TG storage (HCL) by means of 1H-MRS.
On the next day of the trial patients are treated with HBO therapy or room air. A hyperinsulinemic-euglycemic clamp test (120-300 min) with administration of deuterated glucose (D- [6,6-2H2] glucose) (0-120 min) to measure muscular and hepatic insulin resistance will be performed after the end of HBO therapy or room air treatment performed. Indirect calorimetry determines energy consumption and substrate selection (lipid and glucose oxidation) in hyperinsulinaemia. After the end of the HBO therapy or room air treatment and 30 minutes after the start of the clamp test, a sample is taken from the vastus lateralis muscle again.
- Conditions
- Type 2-diabetes
- Being tested
- 100% O2 in oxygen chamber, 21% O2 in oxygen chamber
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% O2 in oxygen chamberDevice
Application of 100% O2 in an hyperbaric oxygen chamber
21% O2 in oxygen chamberDevice
Application of ambient air (21% O2) in an hyperbaric oxygen chamber
| Study group | Role | What they receive |
|---|---|---|
| Hyperbaric oxygenation | Experimental | Patients with T2D receive an 2 hour treatment with 100 % oxygen in a hyperbaric chamber Receives: Device: 100% O2 in oxygen chamber; Device: 21% O2 in oxygen chamber |
| Ambient Air | Experimental | Patients with T2D receive an 2 hour treatment with 21% oxygen in a hyperbaric chamber Receives: Device: 100% O2 in oxygen chamber; Device: 21% O2 in oxygen chamber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of glucose disappearance
measurement of whole body insulin sensitivity with hyperinsulinamic euglycemic clamp test
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start1 Feb 2020
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
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 Type 2-diabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Diabetes Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Roden, Prof., MD, Principal investigator, German Diabetes Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04219215
- Sponsor's protocol ID
- HBO
- Status last verified
- Aug 2023
- First submitted
- 11 Sep 2019
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarabhai T, Mastrototaro L, Kahl S, Bonhof GJ, Jonuscheit M, Bobrov P, Katsuyama H, Guthoff R, Wolkersdorfer M, Herder C, Meuth SG, Dreyer S, Roden M. Hyperbaric oxygen rapidly improves tissue-specific insulin sensitivity and mitochondrial capacity in humans with type 2 diabetes: a randomised placebo-controlled crossover trial. Diabetologia. 2023 Jan;66(1):57-69. doi: 10.1007/s00125-022-05797-0. Epub 2022 Sep 30.
PubMed 36178534
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Hyperbaric Oxygen (HBO) Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04219215
- Acronym / sponsor ID
- HBO
- Conditions
- Type 2-diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- German Diabetes CenterUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 6 Jan 2020 (actual)
- 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.
Diabetes mellitus type 2 (T2D) is characterized by insulin resistance of liver and skeletal muscle, which is at least partly due to impaired muscle mitochondrial function. Long-term HBO therapy, as applied for treating the diabetic foot syndrome, has been shown to improve blood glucose concentrations. To study the underlying mechanisms, we want to examin the short-term effect of HBO treatment on insulin sensitivity and mitochondrial oxidative capacity and production of reactive oxygen species (ROS) in a randomized, double blinded, placebo-controlled cross-over trial.
Detailed description
In total 14 patients are planned. Each participant participates in both experimental parts (100% O2 and ambient air). They are examined immediately after each HBO/ ambient air therapy. The allocation is randomized treated every three weeks with 2-hour therapies using pure O2 or indoor air. Randomized and double-blinded in a cross-over setting, one group of patients with type 2 diabetes is first treated with HBO therapy and the other group is first treated with room air. Here, an ambient pressure of 2.4 ATM is built up and then administered for respiration over a total of 90 minutes of pure O2. Patients are examined on two consecutive days for each part of the study.On the first day serum samples are taken and a sample is taken from the vastus lateralis muscle. A magnetic resonance spectroscopic examination (MRS) is performed on the patient subsequently. In this case, phosphorus metabolites (absolute quantification of ATP, Pi) and the ATP synthase flow rate (fATP) are determined non-invasively by means of 31P MRS and TG storage (HCL) by means of 1H-MRS.
On the next day of the trial patients are treated with HBO therapy or room air. A hyperinsulinemic-euglycemic clamp test (120-300 min) with administration of deuterated glucose (D- [6,6-2H2] glucose) (0-120 min) to measure muscular and hepatic insulin resistance will be performed after the end of HBO therapy or room air treatment performed. Indirect calorimetry determines energy consumption and substrate selection (lipid and glucose oxidation) in hyperinsulinaemia. After the end of the HBO therapy or room air treatment and 30 minutes after the start of the clamp test, a sample is taken from the vastus lateralis muscle again.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyperbaric oxygenation | Experimental | Device: 100% O2 in oxygen chamber, Device: 21% O2 in oxygen chamberPatients with T2D receive an 2 hour treatment with 100 % oxygen in a hyperbaric chamber |
| Ambient Air | Experimental | Device: 100% O2 in oxygen chamber, Device: 21% O2 in oxygen chamberPatients with T2D receive an 2 hour treatment with 21% oxygen in a hyperbaric chamber |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 and ≤ 75 years
- Type 2 diabetes
- HbA1c ≥ 6 and ≤ 9%
- BMI ≤ 35 kg / m2
Key exclusion criteria (10 listed)
- Treatment with thiazolidinedione in the last 6 months
- Uncontrolled hyperglycemia (FPG ≥ 240 mg / dl)
- vitamin supplement (washing out at least 4 weeks)
- Patients requiring revascularization
- Serum CRP ≥ 5 mg / dl
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 |
|---|---|---|
| 100% O2 in oxygen chamberApplication of 100% O2 in an hyperbaric oxygen chamber | Device | Ambient Air, Hyperbaric oxygenation |
| 21% O2 in oxygen chamberApplication of ambient air (21% O2) in an hyperbaric oxygen chamber | Device | Ambient Air, Hyperbaric oxygenation |
Primary outcome
Change in rate of glucose disappearance
Time frame: 12 months
measurement of whole body insulin sensitivity with hyperinsulinamic euglycemic clamp test
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 15 Aug 2023.
- Derived from this study: PubMed 36178534Sarabhai T, Mastrototaro L, Kahl S, Bonhof GJ, Jonuscheit M, Bobrov P, Katsuyama H, Guthoff R, Wolkersdorfer M, Herder C, Meuth SG, Dreyer S, Roden M. Hyperbaric oxygen rapidly improves tissue-specific insulin sensitivity and mitochondrial capacity in humans with type 2 diabetes: a randomised placebo-controlled crossover trial. Diabetologia. 2023 Jan;66(1):57-69. doi: 10.1007/s00125-022-05797-0. Epub 2022 Sep 30.
- Individual participant dataSharing planned: No
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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 100% O2 in oxygen chamber and 21% O2 in oxygen chamber in people with Type 2-diabetes, 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 10 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 15 Aug 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. 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 rate of glucose disappearance (time frame: 12 months). 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 NCT04219215, 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 15 Aug 2023.