- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01197092
The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Rainer Mutschler, MD
- Phone Number: 06232 - 28 90 88 0
- Email: mutschler@cfi-speyer.de
Study Locations
-
-
-
Speyer, Germany, D-67346
- Recruiting
- CFI Centrum für Integrative Medizin
-
Contact:
- Rainer Mutschler, MD
- Phone Number: 06232 - 28 90 88 0
- Email: mutschler@cfi-speyer.de
-
Principal Investigator:
- Rainer Mutschler, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control
|
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.
|
Active Comparator: Verum
|
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.
Intravenous-Blood-Laser-Therapy: the Webermedical device will be used
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c Test (Glycated hemoglobin)
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood count
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Electrolytes
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Liver, pancreatic and kidney retention values
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Lipids: Cholesterol,Triglycerides
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Oxyd LDL (low-density lipoprotein cholesterol)
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Free lipids fasting
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Lipoprotein A
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Fibrinogen
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
CRP (C Reactive protein)
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
LDH-Isoenzymes (Lactate dehydrogenase)
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Homocysteins
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Nutrient IgGs Panels (BiomedicalScreen)
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Insulin, Adiponectin, Leptin
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Potassium, selene, magnesium, zinc in whole blood
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
SHbG, full-testosterone (Androgen-Index)
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
PlasminInhibitor I
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Vitamins B1,B2,B6,B 12, Vitamin D
Time Frame: 4 month average
|
Laboratory test
|
4 month average
|
Collaborators and Investigators
Investigators
- Principal Investigator: Rainer Mutschler, MD
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS-101-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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