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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type II
• Intervention / Treatment: Dietary supplement: Mitochondrial preparations; Dietary supplement: Infusion therapy; Device: Webermedical device; Behavioral: Nutritional therapy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • 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: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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); Dietary supplement: Infusion therapy; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Center for Integrative Medicine, Germany
• Investigators: Principal Investigator: Rainer Mutschler, MD

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Anticipated): January 1, 2011
• Study Completion (Anticipated): January 1, 2011

Study Registration Dates

• First Submitted: September 8, 2010
• First Submitted That Met QC Criteria: September 8, 2010
• First Posted (Estimate): September 9, 2010

Study Record Updates

• Last Update Posted (Estimate): November 16, 2010
• Last Update Submitted That Met QC Criteria: November 15, 2010
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CS-101-01