Ignite Creation Date:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2026-03-01 @ 11:38 PM
Study NCT ID:
NCT01472328
Status:
COMPLETED
Last Update Posted:
2023-06-13
First Post:
2011-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018384', 'term': 'Oxidative Stress'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}, {'id': 'D013312', 'term': 'Stress, Physiological'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-11', 'studyFirstSubmitDate': '2011-11-13', 'studyFirstSubmitQcDate': '2011-11-15', 'lastUpdatePostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal muscle insulin sensitivity', 'timeFrame': '2 years', 'description': 'Determination of the influence of 2 hours hyperoxygenation on insulin sensitivity redox balance and lipid metabolites of skeletal muscle in patients with T2DM'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Oxidative stress', 'Insulin resistance'], 'conditions': ['Obesity', 'Non-insulin-dependent Diabetes Mellitus']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://ddz.de/', 'label': 'Homepage'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 30 years- ≤ 70 years\n* Balanced sex (50: 50)\n* BMI 20- 25 kg/m 2 normal- weight group\n* BMI 35- 39,9 kg/m 2 (Obese typ II)\n\nExclusion Criteria:\n\n* Acute illness 2 weeks before start of examination\n* Autoimmune or Immune disorder deseases (Leukozyten \\< 5000/µl\n* Renal insufficiency (Kreatin \\> 1,5 mg/dl)\n* Heart disease, condition after heart attack\n* Anemia (Hb \\<12g/l, contolled before every day of eximination) or blood donations 4weeks before eximinatin.\n* Participation in another trial within the last 2 weeks\n* Pharmacological- immuno therapy (Cortisol, Antihistaminika, ASS)\n* Thyroid disorders\n* Glitazone or Insulin- Therapy\n* Pragnancy, Lactation, Menstruation\n* Smoking cigaretts, Alcohol- and drug abuse\n* Psychiatric disorders\n* Risk for/ or diagnosed HIV/ AIDS or Hepatitis B/C\n* Liver disease, which are not caused by non- alcoholic steato- hepatitis\n* Working on night shifts or irregular rhythem of night- day\n* Impaired wound healing or clotting disorders\n* Allergic reaction to local anesthetics\n* Malignant cancer'}, 'identificationModule': {'nctId': 'NCT01472328', 'briefTitle': 'Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'German Diabetes Center'}, 'officialTitle': 'Effects of HBO Therapy on Muscular Insulin Resistence in Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'ROS Paradoxon'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hyperbaric oxygen therapy', 'description': 'Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus', 'interventionNames': ['Procedure: HBO therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Hyperbaric room air', 'description': 'Effect of 2 hrs hyperbaric room air herapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus', 'interventionNames': ['Procedure: Hyperbaric room air']}], 'interventions': [{'name': 'HBO therapy', 'type': 'PROCEDURE', 'otherNames': ['oxidative stress', 'antioxidative capacity'], 'description': 'Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus', 'armGroupLabels': ['Hyperbaric oxygen therapy']}, {'name': 'Hyperbaric room air', 'type': 'PROCEDURE', 'otherNames': ['HBO therapy', 'oxidative stress'], 'description': 'Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus', 'armGroupLabels': ['Hyperbaric room air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'German Diabetes Center', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Michael Roden, Prof., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'German Diabetes Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'German Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}