Trial record 18 of 74 for:    Open Studies | "nutritional support"

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
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type II
Dietary Supplement: Mitochondrial preparations
Dietary Supplement: Infusion therapy
Device: Webermedical device
Behavioral: Nutritional therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II

Resource links provided by NLM:


Further study details as provided by Center for Integrative Medicine, Germany:

Primary Outcome Measures:
  • HbA1c Test (Glycated hemoglobin) [ Time Frame: 4 month average ] [ Designated as safety issue: No ]
    Laboratory test


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01197092

Contacts
Contact: Rainer Mutschler, MD 06232 - 28 90 88 0 mutschler@cfi-speyer.de

Locations
Germany
CFI Centrum für Integrative Medizin Recruiting
Speyer, Germany, D-67346
Contact: Rainer Mutschler, MD    06232 - 28 90 88 0    mutschler@cfi-speyer.de   
Principal Investigator: Rainer Mutschler, MD         
Sponsors and Collaborators
Center for Integrative Medicine, Germany
Investigators
Principal Investigator: Rainer Mutschler, MD
  More Information

No publications provided

Responsible Party: Rainer Mutschler, Center for Integrative Medicine
ClinicalTrials.gov Identifier: NCT01197092     History of Changes
Other Study ID Numbers: CS-101-01
Study First Received: September 8, 2010
Last Updated: November 15, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Institutional Review Board

Keywords provided by Center for Integrative Medicine, Germany:
Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 21, 2014