Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 8:10 AM
Study NCT ID:
NCT01197092
Status:
UNKNOWN
Last Update Posted:
2010-11-16
First Post:
2010-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018718', 'term': 'Home Infusion Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006699', 'term': 'Home Care Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-15', 'studyFirstSubmitDate': '2010-09-08', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c Test (Glycated hemoglobin)', 'timeFrame': '4 month average', 'description': 'Laboratory test'}], 'secondaryOutcomes': [{'measure': 'Blood count', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Electrolytes', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Liver, pancreatic and kidney retention values', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Lipids: Cholesterol,Triglycerides', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Oxyd LDL (low-density lipoprotein cholesterol)', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Free lipids fasting', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Lipoprotein A', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Fibrinogen', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'CRP (C Reactive protein)', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'LDH-Isoenzymes (Lactate dehydrogenase)', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Homocysteins', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Nutrient IgGs Panels (BiomedicalScreen)', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Insulin, Adiponectin, Leptin', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Potassium, selene, magnesium, zinc in whole blood', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'SHbG, full-testosterone (Androgen-Index)', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'PlasminInhibitor I', 'timeFrame': '4 month average', 'description': 'Laboratory test'}, {'measure': 'Vitamins B1,B2,B6,B 12, Vitamin D', 'timeFrame': '4 month average', 'description': 'Laboratory test'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes'], 'conditions': ['Diabetes Mellitus, Type II']}, 'descriptionModule': {'briefSummary': 'A treatment with the concept of mitochondrial medication developed by Dr Heinrich Kremer can demonstrably improve and successfully treat actual parameters of Diabetes Mellitus II as well as its risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women between the ages of 18 and 60\n* recently diagnosed Diabetes Type II (within the last 12 months)\n\nExclusion Criteria:\n\n* no orally-taken medication up to present\n* no insulin therapy\n* no diseases resulting from diabetes like Nephropathy, Neuropathy, Angiopathy or Retinopathy\n* fasting blood sugar values in the morning under 200mmol\n* sufficient production of insulin'}, 'identificationModule': {'nctId': 'NCT01197092', 'briefTitle': 'The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II', 'organization': {'class': 'OTHER', 'fullName': 'Center for Integrative Medicine, Germany'}, 'officialTitle': 'A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II', 'orgStudyIdInfo': {'id': 'CS-101-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Verum', 'interventionNames': ['Dietary Supplement: Mitochondrial preparations', 'Dietary Supplement: Infusion therapy', 'Device: Webermedical device', 'Behavioral: Nutritional therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'interventionNames': ['Behavioral: Nutritional therapy']}], 'interventions': [{'name': 'Mitochondrial preparations', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral therapy with mitochondrial preparations based on recipes of Dr Kremer and the Tisso company:\n\nProEMSan (large intestinal symbionts with 31 strains of bacteria) Pro Basan (small intestinal symbionts) ProSirtusan (Polyphenol-mix and vitamins) ProVita D3 (Vitamin D3 supplement) ProOmega (Omega 3-fatty acid preparation) ProCarnitin (Carnitine-preparation) ProSango Vital (trace element preparation)', 'armGroupLabels': ['Verum']}, {'name': 'Infusion therapy', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Infusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants.', 'armGroupLabels': ['Verum']}, {'name': 'Webermedical device', 'type': 'DEVICE', 'description': 'Intravenous-Blood-Laser-Therapy: the Webermedical device will be used', 'armGroupLabels': ['Verum']}, {'name': 'Nutritional therapy', 'type': 'BEHAVIORAL', 'description': 'Nutritional therapy based on IgG-blood results. Significant antibody-formation against foodstuffs will be ascertained (in foodstuffs evaluated through the BioMedicalScreen), will be taken out of the diet - the background being the additional lowering of risk potential of those antibodies causing the so called "silent inflammation" (sub-clinical inflammation) -ultimately an anti-inflammatory diet will be given in the protocol. The following have special focus: gluten, cow\'s milk, fish, meat, nuts.', 'armGroupLabels': ['Control', 'Verum']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D-67346', 'city': 'Speyer', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rainer Mutschler, MD', 'role': 'CONTACT', 'email': 'mutschler@cfi-speyer.de', 'phone': '06232 - 28 90 88 0'}, {'name': 'Rainer Mutschler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CFI Centrum für Integrative Medizin', 'geoPoint': {'lat': 49.32083, 'lon': 8.43111}}], 'centralContacts': [{'name': 'Rainer Mutschler, MD', 'role': 'CONTACT', 'email': 'mutschler@cfi-speyer.de', 'phone': '06232 - 28 90 88 0'}], 'overallOfficials': [{'name': 'Rainer Mutschler, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Integrative Medicine, Germany', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Rainer Mutschler', 'oldOrganization': 'Center for Integrative Medicine'}}}}