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

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 8, 2010

Last Updated Date

November 15, 2010

Start Date ^ICMJE

November 2010

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HbA1c Test (Glycated hemoglobin) [ Time Frame: 4 month average ] [ Designated as safety issue: No ]

Laboratory test

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01197092 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Mellitus, Type II

Intervention ^ICMJE

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.

Study Arm (s)

Active Comparator: Verum
Interventions:
- Dietary Supplement: Mitochondrial preparations
- Dietary Supplement: Infusion therapy
- Device: Webermedical device
- Behavioral: Nutritional therapy
Experimental: Control
Intervention: Behavioral: Nutritional therapy

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2011

Estimated Primary Completion Date

January 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Rainer Mutschler, MD

06232 - 28 90 88 0

mutschler@cfi-speyer.de

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01197092

Other Study ID Numbers ^ICMJE

CS-101-01

Has Data Monitoring Committee

Responsible Party

Rainer Mutschler, Center for Integrative Medicine

Study Sponsor ^ICMJE

Center for Integrative Medicine, Germany

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Rainer Mutschler, MD

Information Provided By

Center for Integrative Medicine, Germany

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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