Diabetes Mellitus, Type IIPhase 2NCT01197092
The Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
A Phase 2 study testing Mitochondrial preparations, Infusion therapy and Webermedical device in people with Diabetes Mellitus, Type II, run by Center for Integrative Medicine, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- Mitochondrial preparations, Infusion therapy and Webermedical device
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Jan 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- men and women between the ages of 18 and 60
- recently diagnosed Diabetes Type II (within the last 12 months)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
CFI Centrum für Integrative Medizin
Speyer, D-67346
Rainer Mutschler, MD, 06232 - 28 90 88 0, mutschler@cfi-speyer.de
Rainer Mutschler, MD
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- Mitochondrial preparations, Infusion therapy, Webermedical device, Nutritional therapy
- Keywords
- Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitochondrial preparationsDietary supplement
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 therapyDietary supplement
Infusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants.
Webermedical deviceDevice
Intravenous-Blood-Laser-Therapy: the Webermedical device will be used
Nutritional therapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Verum | Active comparator | Not described Receives: Dietary Supplement: Mitochondrial preparations; Dietary Supplement: Infusion therapy; Device: Webermedical device; Behavioral: Nutritional therapy |
| Control | Experimental | Not described Receives: Behavioral: Nutritional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c Test (Glycated hemoglobin)
Laboratory test
Measured: 4 month average
Secondary outcomes (17)
Blood count
Laboratory test
Measured: 4 month average
Electrolytes
Laboratory test
Measured: 4 month average
Liver, pancreatic and kidney retention values
Laboratory test
Measured: 4 month average
Lipids: Cholesterol,Triglycerides
Laboratory test
Measured: 4 month average
Oxyd LDL (low-density lipoprotein cholesterol)
Laboratory test
Measured: 4 month average
Free lipids fasting
Laboratory test
Measured: 4 month average
Lipoprotein A
Laboratory test
Measured: 4 month average
Fibrinogen
Laboratory test
Measured: 4 month average
CRP (C Reactive protein)
Laboratory test
Measured: 4 month average
LDH-Isoenzymes (Lactate dehydrogenase)
Laboratory test
Measured: 4 month average
Homocysteins
Laboratory test
Measured: 4 month average
Nutrient IgGs Panels (BiomedicalScreen)
Laboratory test
Measured: 4 month average
Insulin, Adiponectin, Leptin
Laboratory test
Measured: 4 month average
Potassium, selene, magnesium, zinc in whole blood
Laboratory test
Measured: 4 month average
SHbG, full-testosterone (Androgen-Index)
Laboratory test
Measured: 4 month average
PlasminInhibitor I
Laboratory test
Measured: 4 month average
Vitamins B1,B2,B6,B 12, Vitamin D
Laboratory test
Measured: 4 month average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2011 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Integrative Medicine, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Rainer Mutschler, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197092
- Sponsor's protocol ID
- CS-101-01
- Status last verified
- Sep 2010
- First submitted
- 8 Sep 2010
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Evaluating the Effects of a Regenerative Mitochondrial Medication on Physiological Parameters in Case of Diabetes Mellitus Type II
- ClinicalTrials.gov ID
- NCT01197092
- Acronym / sponsor ID
- CS-101-01
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Center for Integrative Medicine, GermanyUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jan 2011 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Active comparator | Dietary Supplement: Mitochondrial preparations, Dietary Supplement: Infusion therapy, Device: Webermedical device, Behavioral: Nutritional therapy |
| Control | Experimental | Behavioral: Nutritional therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- men and women between the ages of 18 and 60
- recently diagnosed Diabetes Type II (within the last 12 months)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitochondrial preparationsOral 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 | Verum |
| Infusion therapyInfusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants. | Dietary supplement | Verum |
| Webermedical deviceIntravenous-Blood-Laser-Therapy: the Webermedical device will be used | Device | Verum |
| Nutritional therapyNutritional 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. | Behavioural | Control, Verum |
Primary outcome
HbA1c Test (Glycated hemoglobin)
Time frame: 4 month average
Laboratory test
17 secondary outcomes
Blood count
Time frame: 4 month average
Electrolytes
Time frame: 4 month average
Liver, pancreatic and kidney retention values
Time frame: 4 month average
Lipids: Cholesterol,Triglycerides
Time frame: 4 month average
Oxyd LDL (low-density lipoprotein cholesterol)
Time frame: 4 month average
Free lipids fasting
Time frame: 4 month average
Lipoprotein A
Time frame: 4 month average
Fibrinogen
Time frame: 4 month average
CRP (C Reactive protein)
Time frame: 4 month average
LDH-Isoenzymes (Lactate dehydrogenase)
Time frame: 4 month average
Homocysteins
Time frame: 4 month average
Nutrient IgGs Panels (BiomedicalScreen)
Time frame: 4 month average
Insulin, Adiponectin, Leptin
Time frame: 4 month average
Potassium, selene, magnesium, zinc in whole blood
Time frame: 4 month average
SHbG, full-testosterone (Androgen-Index)
Time frame: 4 month average
PlasminInhibitor I
Time frame: 4 month average
Vitamins B1,B2,B6,B 12, Vitamin D
Time frame: 4 month average
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Mutschler, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mitochondrial preparations, Infusion therapy and Webermedical device in people with Diabetes Mellitus, Type II, run by Center for Integrative Medicine, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rainer Mutschler, MD (06232 - 28 90 88 0, mutschler@cfi-speyer.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c Test (Glycated hemoglobin) (time frame: 4 month average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2010.