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

June 11, 2023 updated by: German Diabetes Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Düsseldorf, Germany, 40225
        • German Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hyperbaric oxygen therapy
Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Procedure: HBO therapy
Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Other Names:
  • oxidative stress
  • antioxidative capacity
Sham Comparator: Hyperbaric room air
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
Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
Other Names:
  • oxidative stress
  • HBO therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skeletal muscle insulin sensitivity
Time Frame: 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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Diabetes Center

Collaborators

Heinrich-Heine University, Duesseldorf

Investigators

  • Principal Investigator: Michael Roden, Prof., MD, German Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2012

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 13, 2011

First Submitted That Met QC Criteria

November 15, 2011

First Posted (Estimated)

November 16, 2011

Study Record Updates

Last Update Posted (Actual)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROS Paradoxon

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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