NCT01197092

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

November 16, 2010

Status Verified

September 1, 2010

Enrollment Period

2 months

First QC Date

September 8, 2010

Last Update Submit

November 15, 2010

Conditions

Diabetes Mellitus, Type II

Keywords

Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c Test (Glycated hemoglobin)

    Laboratory test

    4 month average

Secondary Outcomes (17)

  • Blood count

    4 month average

  • Electrolytes

    4 month average

  • Liver, pancreatic and kidney retention values

    4 month average

  • Lipids: Cholesterol,Triglycerides

    4 month average

  • Oxyd LDL (low-density lipoprotein cholesterol)

    4 month average

  • +12 more secondary outcomes

Study Arms (2)

Verum

ACTIVE COMPARATOR
Dietary Supplement: Mitochondrial preparationsDietary Supplement: Infusion therapyDevice: Webermedical deviceBehavioral: Nutritional therapy

Control

EXPERIMENTAL
Behavioral: Nutritional therapy

Interventions

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)

Verum
Infusion therapyDIETARY_SUPPLEMENT

Infusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants.

Verum
Webermedical deviceDEVICE

Intravenous-Blood-Laser-Therapy: the Webermedical device will be used

Verum
Nutritional therapyBEHAVIORAL

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.

ControlVerum

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • men and women between the ages of 18 and 60
  • recently diagnosed Diabetes Type II (within the last 12 months)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CFI Centrum für Integrative Medizin

Speyer, D-67346, Germany

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Home Infusion TherapyNutrition Therapy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeuticsHome Care ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rainer Mutschler, MD

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rainer Mutschler, MD

CONTACT

06232 - 28 90 88 0mutschler@cfi-speyer.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 9, 2010

Study Start

November 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

November 16, 2010

Record last verified: 2010-09

Locations

DE(1)