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

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ClinicalTrials.gov Identifier: NCT01472328
Recruitment Status : Unknown
Verified November 2011 by julia szendrödi, German Diabetes Center.
Recruitment status was:  Not yet recruiting
First Posted : November 16, 2011
Last Update Posted : November 22, 2011
Sponsor:
Collaborator:
Heinrich-Heine University, Duesseldorf
Information provided by (Responsible Party):
julia szendrödi, 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.

Condition or disease Intervention/treatment Phase
Obesity Non-insulin-dependent Diabetes Mellitus Procedure: HBO therapy Procedure: Hyperbaric room air Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
Study Start Date : March 2012
Estimated Primary Completion Date : March 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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:
  • HBO therapy
  • oxidative stress




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: julia szendrödi, MD, PhD, German Diabetes Center
ClinicalTrials.gov Identifier: NCT01472328     History of Changes
Other Study ID Numbers: ROS Paradoxon
First Posted: November 16, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Keywords provided by julia szendrödi, German Diabetes Center:
Oxidative stress
Insulin resistance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs