The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
Primary Purpose
Diabetes Mellitus, Type II
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Mitochondrial preparations
Infusion therapy
Webermedical device
Nutritional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type II focused on measuring Diabetes
Eligibility 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
Sites / Locations
- CFI Centrum für Integrative MedizinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Verum
Control
Arm Description
Outcomes
Primary Outcome Measures
HbA1c Test (Glycated hemoglobin)
Laboratory test
Secondary Outcome Measures
Blood count
Laboratory test
Electrolytes
Laboratory test
Liver, pancreatic and kidney retention values
Laboratory test
Lipids: Cholesterol,Triglycerides
Laboratory test
Oxyd LDL (low-density lipoprotein cholesterol)
Laboratory test
Free lipids fasting
Laboratory test
Lipoprotein A
Laboratory test
Fibrinogen
Laboratory test
CRP (C Reactive protein)
Laboratory test
LDH-Isoenzymes (Lactate dehydrogenase)
Laboratory test
Homocysteins
Laboratory test
Nutrient IgGs Panels (BiomedicalScreen)
Laboratory test
Insulin, Adiponectin, Leptin
Laboratory test
Potassium, selene, magnesium, zinc in whole blood
Laboratory test
SHbG, full-testosterone (Androgen-Index)
Laboratory test
PlasminInhibitor I
Laboratory test
Vitamins B1,B2,B6,B 12, Vitamin D
Laboratory test
Full Information
NCT ID
NCT01197092
First Posted
September 8, 2010
Last Updated
November 15, 2010
Sponsor
Center for Integrative Medicine, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01197092
Brief Title
The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
Official Title
A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2011 (Anticipated)
Study Completion Date
January 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Center for Integrative Medicine, Germany
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type II
Keywords
Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Verum
Arm Type
Active Comparator
Arm Title
Control
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Mitochondrial preparations
Intervention Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
Infusion therapy
Intervention Description
Infusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants.
Intervention Type
Device
Intervention Name(s)
Webermedical device
Intervention Description
Intravenous-Blood-Laser-Therapy: the Webermedical device will be used
Intervention Type
Behavioral
Intervention Name(s)
Nutritional therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c Test (Glycated hemoglobin)
Description
Laboratory test
Time Frame
4 month average
Secondary Outcome Measure Information:
Title
Blood count
Description
Laboratory test
Time Frame
4 month average
Title
Electrolytes
Description
Laboratory test
Time Frame
4 month average
Title
Liver, pancreatic and kidney retention values
Description
Laboratory test
Time Frame
4 month average
Title
Lipids: Cholesterol,Triglycerides
Description
Laboratory test
Time Frame
4 month average
Title
Oxyd LDL (low-density lipoprotein cholesterol)
Description
Laboratory test
Time Frame
4 month average
Title
Free lipids fasting
Description
Laboratory test
Time Frame
4 month average
Title
Lipoprotein A
Description
Laboratory test
Time Frame
4 month average
Title
Fibrinogen
Description
Laboratory test
Time Frame
4 month average
Title
CRP (C Reactive protein)
Description
Laboratory test
Time Frame
4 month average
Title
LDH-Isoenzymes (Lactate dehydrogenase)
Description
Laboratory test
Time Frame
4 month average
Title
Homocysteins
Description
Laboratory test
Time Frame
4 month average
Title
Nutrient IgGs Panels (BiomedicalScreen)
Description
Laboratory test
Time Frame
4 month average
Title
Insulin, Adiponectin, Leptin
Description
Laboratory test
Time Frame
4 month average
Title
Potassium, selene, magnesium, zinc in whole blood
Description
Laboratory test
Time Frame
4 month average
Title
SHbG, full-testosterone (Androgen-Index)
Description
Laboratory test
Time Frame
4 month average
Title
PlasminInhibitor I
Description
Laboratory test
Time Frame
4 month average
Title
Vitamins B1,B2,B6,B 12, Vitamin D
Description
Laboratory test
Time Frame
4 month average
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rainer Mutschler, MD
Phone
06232 - 28 90 88 0
Email
mutschler@cfi-speyer.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Mutschler, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
CFI Centrum für Integrative Medizin
City
Speyer
ZIP/Postal Code
D-67346
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rainer Mutschler, MD
Phone
06232 - 28 90 88 0
Email
mutschler@cfi-speyer.de
First Name & Middle Initial & Last Name & Degree
Rainer Mutschler, MD
12. IPD Sharing Statement
Learn more about this trial
The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
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