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

Phase 2

• Conditions: Diabetes Mellitus, Type II
• Interventions: Dietary Supplement: Mitochondrial preparations; Dietary Supplement: Infusion therapy; Device: Webermedical device; Behavioral: Nutritional therapy

• Registration Number: NCT01197092
• Lead Sponsor: Center for Integrative Medicine, Germany

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 available

Study Timeline

• Status Verified: 2010-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-08
• Study First Posted: 2010-09-09
• Study Start: 2010-11
• Last Update Submitted: 2010-11-15
• Last Update Posted: 2010-11-16
• Primary Completion: 2011-01
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum	Mitochondrial preparations	-
Verum	Infusion therapy	-
Verum	Webermedical device	-
Verum	Nutritional therapy	-
Control	Nutritional therapy	-

Primary Outcome Measures

Name	Time	Method
HbA1c Test (Glycated hemoglobin)	4 month average	Laboratory test

Secondary Outcome Measures

Name	Time	Method
Blood count	4 month average	Laboratory test
Electrolytes	4 month average	Laboratory test
Liver, pancreatic and kidney retention values	4 month average	Laboratory test
Lipids: Cholesterol,Triglycerides	4 month average	Laboratory test
Oxyd LDL (low-density lipoprotein cholesterol)	4 month average	Laboratory test
Free lipids fasting	4 month average	Laboratory test
Lipoprotein A	4 month average	Laboratory test
Fibrinogen	4 month average	Laboratory test
CRP (C Reactive protein)	4 month average	Laboratory test
LDH-Isoenzymes (Lactate dehydrogenase)	4 month average	Laboratory test
Homocysteins	4 month average	Laboratory test
Nutrient IgGs Panels (BiomedicalScreen)	4 month average	Laboratory test
Insulin, Adiponectin, Leptin	4 month average	Laboratory test
Potassium, selene, magnesium, zinc in whole blood	4 month average	Laboratory test
SHbG, full-testosterone (Androgen-Index)	4 month average	Laboratory test
PlasminInhibitor I	4 month average	Laboratory test
Vitamins B1,B2,B6,B 12, Vitamin D	4 month average	Laboratory test

Trial Locations

Locations (1)

CFI Centrum für Integrative Medizin; 🇩🇪 Speyer, Germany