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

German Diabetes Center

Status: Completed

Conditions: Obesity; Non-insulin-dependent Diabetes Mellitus

Treatments: Procedure: Hyperbaric room air; Procedure: HBO therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01472328

ROS Paradoxon

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Hyperbaric oxygen therapy

Experimental group

Description:

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

Treatment:

Procedure: HBO therapy

Hyperbaric room air

Sham Comparator group

Description:

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

Treatment:

Procedure: Hyperbaric room air