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

Diabetes Mellitus, Type II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01197092
• Other study ID #: CS-101-01
• Status: Recruiting
• Phase: Phase 2
• First received: September 8, 2010
• Last updated: November 15, 2010
• Start date: November 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2010
• Source: Center for Integrative Medicine, Germany
• Contact: Rainer Mutschler, MD
• Phone: 06232 - 28 90 88 0
• Email: mutschler[@]cfi-speyer.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes Mellitus, Type II

Intervention

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
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.

Locations

Country	Name	City	State
Germany	CFI Centrum für Integrative Medizin	Speyer

Sponsors (1)

Lead Sponsor	Collaborator
Center for Integrative Medicine, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c Test (Glycated hemoglobin)	Laboratory test	4 month average	No
Secondary	Blood count	Laboratory test	4 month average	No
Secondary	Electrolytes	Laboratory test	4 month average	No
Secondary	Liver, pancreatic and kidney retention values	Laboratory test	4 month average	No
Secondary	Lipids: Cholesterol,Triglycerides	Laboratory test	4 month average	No
Secondary	Oxyd LDL (low-density lipoprotein cholesterol)	Laboratory test	4 month average	No
Secondary	Free lipids fasting	Laboratory test	4 month average	No
Secondary	Lipoprotein A	Laboratory test	4 month average	No
Secondary	Fibrinogen	Laboratory test	4 month average	No
Secondary	CRP (C Reactive protein)	Laboratory test	4 month average	No
Secondary	LDH-Isoenzymes (Lactate dehydrogenase)	Laboratory test	4 month average	No
Secondary	Homocysteins	Laboratory test	4 month average	No
Secondary	Nutrient IgGs Panels (BiomedicalScreen)	Laboratory test	4 month average	No
Secondary	Insulin, Adiponectin, Leptin	Laboratory test	4 month average	No
Secondary	Potassium, selene, magnesium, zinc in whole blood	Laboratory test	4 month average	No
Secondary	SHbG, full-testosterone (Androgen-Index)	Laboratory test	4 month average	No
Secondary	PlasminInhibitor I	Laboratory test	4 month average	No
Secondary	Vitamins B1,B2,B6,B 12, Vitamin D	Laboratory test	4 month average	No