Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01472328

Enrollment

Registered

2011-11-16

Start date

2012-03-31

Completion date

2015-08-31

Last updated

2023-06-13

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

Conditions

Non-insulin-dependent Diabetes Mellitus, Obesity

Keywords

Oxidative stress, Insulin resistance

Brief 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.

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.

Interventions

PROCEDUREHBO therapy

Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

PROCEDUREHyperbaric room air

Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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 * 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

Design outcomes

Primary

Measure	Time frame	Description
Skeletal muscle insulin sensitivity	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026