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Completed

NCT Number: NCT01472328

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

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.

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Key information

Conditions

Obesity Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Non-Insulin-Dependent Diabetes Mellitus Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Diabetes Center

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HBO therapy

Procedure

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

Hyperbaric room air

Procedure

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

German Diabetes Center

Other

Collaborators

  • Heinrich-Heine University, Duesseldorf

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Nov 16, 2011
Registry last updated
Jun 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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