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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01472328
• Other study ID #: ROS Paradoxon
• Status: Completed
• Phase: N/A
• Start date: March 2012
• Est. completion date: August 2015

Study information

• Verified date: June 2023
• Source: German Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Non-insulin-dependent Diabetes Mellitus
• Obesity

Intervention

Procedure:
• HBO therapy
Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
• Hyperbaric room air
Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus

Locations

Country	Name	City	State
Germany	German Diabetes Center	Düsseldorf

Sponsors (2)

Lead Sponsor	Collaborator
German Diabetes Center	Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

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