Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04219215 |
| Other study ID # |
HBO |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 1, 2020 |
| Est. completion date |
September 20, 2022 |
Study information
| Verified date |
August 2023 |
| Source |
German Diabetes Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
