The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Center for Integrative Medicine, Germany.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Center for Integrative Medicine, Germany
Information provided by:
Center for Integrative Medicine, Germany
ClinicalTrials.gov Identifier:
NCT01197092
First received: September 8, 2010
Last updated: November 15, 2010
Last verified: September 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type II |
Dietary Supplement: Mitochondrial preparations Dietary Supplement: Infusion therapy Device: Webermedical device Behavioral: Nutritional therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes
Diabetes Medicines
Diabetes Type 2
Nutritional Support
Potassium
U.S. FDA Resources
Further study details as provided by Center for Integrative Medicine, Germany:
Primary Outcome Measures:
- HbA1c Test (Glycated hemoglobin) [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
Secondary Outcome Measures:
- Blood count [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Electrolytes [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Liver, pancreatic and kidney retention values [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Lipids: Cholesterol,Triglycerides [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Oxyd LDL (low-density lipoprotein cholesterol) [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Free lipids fasting [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Lipoprotein A [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Fibrinogen [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- CRP (C Reactive protein) [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- LDH-Isoenzymes (Lactate dehydrogenase) [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Homocysteins [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Nutrient IgGs Panels (BiomedicalScreen) [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Insulin, Adiponectin, Leptin [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Potassium, selene, magnesium, zinc in whole blood [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- SHbG, full-testosterone (Androgen-Index) [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- PlasminInhibitor I [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
- Vitamins B1,B2,B6,B 12, Vitamin D [ Time Frame: 4 month average ] [ Designated as safety issue: No ]Laboratory test
| Estimated Enrollment: | 40 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | January 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Verum |
Dietary Supplement: Mitochondrial preparations
Oral therapy with mitochondrial preparations based on recipes of Dr Kremer and the Tisso company: ProEMSan (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) Infusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants.
Device: Webermedical device
Intravenous-Blood-Laser-Therapy: the Webermedical device will be used
Behavioral: Nutritional therapy
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.
|
| Experimental: Control |
Behavioral: Nutritional therapy
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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- men and women between the ages of 18 and 60
- recently diagnosed Diabetes Type II (within the last 12 months)
Exclusion Criteria:
- no orally-taken medication up to present
- no insulin therapy
- no diseases resulting from diabetes like Nephropathy, Neuropathy, Angiopathy or Retinopathy
- fasting blood sugar values in the morning under 200mmol
- sufficient production of insulin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01197092
Contacts
| Contact: Rainer Mutschler, MD | 06232 - 28 90 88 0 | mutschler@cfi-speyer.de |
Locations
| Germany | |
| CFI Centrum für Integrative Medizin | Recruiting |
| Speyer, Germany, D-67346 | |
| Contact: Rainer Mutschler, MD 06232 - 28 90 88 0 mutschler@cfi-speyer.de | |
| Principal Investigator: Rainer Mutschler, MD | |
Sponsors and Collaborators
Center for Integrative Medicine, Germany
Investigators
| Principal Investigator: | Rainer Mutschler, MD |
More Information
No publications provided
| Responsible Party: | Rainer Mutschler, Center for Integrative Medicine |
| ClinicalTrials.gov Identifier: | NCT01197092 History of Changes |
| Other Study ID Numbers: | CS-101-01 |
| Study First Received: | September 8, 2010 |
| Last Updated: | November 15, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices United States: Institutional Review Board |
Keywords provided by Center for Integrative Medicine, Germany:
|
Diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013