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

Not Applicable

Completed

• Conditions: Non-insulin-dependent Diabetes Mellitus; Obesity

• Registration Number: NCT01472328
• Lead Sponsor: German Diabetes Center

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.

Study Timeline

• Study First Submitted: 2011-11-13
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Study Start: 2012-03
• Primary Completion: 2015-03
• Study Completion: 2015-08
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-11
• Last Update Posted: 2023-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

German Diabetes Center; 🇩🇪 Düsseldorf, Germany