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

This study is not yet open for participant recruitment.
Verified November 2011 by German Diabetes Center
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
julia szendrödi, German Diabetes Center
ClinicalTrials.gov Identifier:
NCT01472328
First received: November 13, 2011
Last updated: November 20, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Non-insulin-dependent Diabetes Mellitus
 Procedure: HBO therapy
Procedure: Hyperbaric room air

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by German Diabetes Center:

Primary Outcome Measures:
  • Skeletal muscle insulin sensitivity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Determination of the influence of 2 hours hyperoxygenation on insulin sensitivity redox balance and lipid metabolites of skeletal muscle in patients with T2DM


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • HBO therapy
  • oxidative stress

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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01472328

Contacts
Contact: Julia Szendrödi, MD, PhD 0049 0211 3382 203 julia.szendrödi@ddz.uni-duesseldorf.de

Locations
Germany
Deutsches Diabetes Zentrum Not yet recruiting
Düsseldorf, Germany, 40225
Contact: Julia Szendrödi, MD, PhD     0049 0211 3382 203     julia.szendrödi@ddz.uni-duesseldorf.de    
Sponsors and Collaborators
German Diabetes Center
Heinrich-Heine University, Duesseldorf
Investigators
Principal Investigator: Julia Szendrödi, MD, PhD German Diabetes Center
  More Information

No publications provided

Responsible Party: julia szendrödi, MD, PhD, German Diabetes Center
ClinicalTrials.gov Identifier: NCT01472328     History of Changes
Other Study ID Numbers: ROS Paradoxon
Study First Received: November 13, 2011
Last Updated: November 20, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by German Diabetes Center:
Oxidative stress
Insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013