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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Non-insulin-dependent Diabetes Mellitus

Intervention / Treatment
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* Procedure: HBO therapy
* Procedure: Hyperbaric room air


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hyperbaric oxygen therapy<br>Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus | Procedure: HBO therapy<br>* Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus<br>* Other names: antioxidative capacity;|
| Sham Comparator: Hyperbaric room air<br>Effect of 2 hrs hyperbaric room air herapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus | Procedure: Hyperbaric room air<br>* Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus<br>* Other names: oxidative stress;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxidative stress, Insulin resistance