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Acute Hyperbaric Oxygen Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in T2D

Acute Hyperbaric Oxygen (HBO) Treatment Increases Hepatic Insulin Sensitivity and Muscle Reactive Oxygen Species in Type 2 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04219215
Enrollment
12
Registered
2020-01-06
Start date
2020-02-01
Completion date
2022-09-20
Last updated
2023-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2-diabetes

Brief 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. 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.

Interventions

DEVICE100% O2 in oxygen chamber

Application of 100% O2 in an hyperbaric oxygen chamber

DEVICE21% O2 in oxygen chamber

Application of ambient air (21% O2) in an hyperbaric oxygen chamber

Sponsors

German Diabetes Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 and ≤ 75 years * Type 2 diabetes * HbA1c ≥ 6 and ≤ 9% * BMI ≤ 35 kg / m2

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Change in rate of glucose disappearance12 monthsmeasurement of whole body insulin sensitivity with hyperinsulinamic euglycemic clamp test

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026