The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II

Study Overview
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Brief Summary
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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.

Official Title
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A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II

Conditions
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Diabetes Mellitus, Type II

Intervention / Treatment
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* Dietary Supplement: Mitochondrial preparations
* Dietary Supplement: Infusion therapy
* Device: Webermedical device
* Behavioral: Nutritional therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Verum<br> | Dietary Supplement: Mitochondrial preparations<br>* 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)<br>Dietary Supplement: Infusion therapy<br>* Infusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants.<br>Device: Webermedical device<br>* Intravenous-Blood-Laser-Therapy: the Webermedical device will be used<br>Behavioral: Nutritional therapy<br>* 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.<br>|
| Experimental: Control<br> | Behavioral: Nutritional therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c Test (Glycated hemoglobin) | Laboratory test | 4 month average | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood count | Laboratory test | 4 month average | 
| Electrolytes | Laboratory test | 4 month average | 
| Liver, pancreatic and kidney retention values | Laboratory test | 4 month average | 
| Lipids: Cholesterol,Triglycerides | Laboratory test | 4 month average | 
| Oxyd LDL (low-density lipoprotein cholesterol) | Laboratory test | 4 month average | 
| Free lipids fasting | Laboratory test | 4 month average | 
| Lipoprotein A | Laboratory test | 4 month average | 
| Fibrinogen | Laboratory test | 4 month average | 
| CRP (C Reactive protein) | Laboratory test | 4 month average | 
| LDH-Isoenzymes (Lactate dehydrogenase) | Laboratory test | 4 month average | 
| Homocysteins | Laboratory test | 4 month average | 
| Nutrient IgGs Panels (BiomedicalScreen) | Laboratory test | 4 month average | 
| Insulin, Adiponectin, Leptin | Laboratory test | 4 month average | 
| Potassium, selene, magnesium, zinc in whole blood | Laboratory test | 4 month average | 
| SHbG, full-testosterone (Androgen-Index) | Laboratory test | 4 month average | 
| PlasminInhibitor I | Laboratory test | 4 month average | 
| Vitamins B1,B2,B6,B 12, Vitamin D | Laboratory test | 4 month average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes