Diabetes Mellitus Type II
Conditions
Keywords
diabetes
Brief summary
This is a pilot study to investigate the effect of e.-coli-nissle as supporting therapy to antidiabetic standard care in patients with diabetes mellitus type II
Interventions
DRUGe.-coli-nissle
1 ml qd for 24 weeks
Sponsors
Ardeypharm GmbH
GWT-TUD GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diabetes mellitus type 2; * HbA1c \>7 % (stable für 6 months, max. variation of 0,5%) * stable oral antidiabetic therapy for 6 months with Metformin, Vildagliptin, Gliniden or without oral Antidiabetics * age of 45 to \<80 years (men and women)
Exclusion criteria
* Myocardial infarction or stroke within the last 5 years * Therapy with acarbose * Acute peripheral arterial disease within the last 12 months * Instable metabolic situation * Uncontrolled hypertension * Body-Mass-Index ≥ 35 kg/m² * Smokers * Daily consumption of probiotic food * Malignant disease within the last 5 years * Status post transplantation * Immunosuppressive therapy within the last 3 months * Therapy with antibiotics * Macroalbuminuria * Severe liver disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in HbA1c levels | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| change in insulin resistance/secretion | 24 weeks |
| change in lipid parameters | 24 weeks |
| change in parameters of oxidative stress | 24 weeks |
| change in gastrointestinal condition | 24 weeks |
Countries
Germany
Outcome results
None listed