Status:
COMPLETED
Metabolic Effects of Lactobacillus Reuteri DSM 17938 in Type 2 Diabetes
Lead Sponsor:
Vastra Gotaland Region
Collaborating Sponsors:
BioGaia AB
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
Recent data suggest that the trillions of bacteria in gastrointestinal tracts (gut microbiota) can function as an environmental factor that modulates the amount of body fat. Obese individuals have an ...
Detailed Description
This is a double-blind, placebo controlled randomised study with three parallel groups of type 2 diabetes (T2D) patients receiving either placebo, Lactobacillus reuteri DSM 17938, 1 x 108 (colony-form...
Eligibility Criteria
Inclusion
- Type 2 diabetes with a duration \> 6 months
- Adults 50- 75 years of age
- Abdominal obesity (females waist \> 80 cm; males waist \> 94 cm)
- HbA1c 50-90 mmol/mol
- Anti-hyperglycemic treatment with lifestyle, oral agents and insulin
- Written informed consent
- Stated availability throughout the study period
- Fasting C-peptide \> 0.27 nmol/l
- BMI 25-40 kg/m2
- Stable weight (± 5 kg) and HbA1c (± 5 mmol/mol) for 6 months
Exclusion
- Autoimmune diabetes eg type 1 diabetes
- Psychiatric illness e g claustrophobia or alcoholism, cancer diagnosis and no foreseeable need of treatment with corticosteroids or antibiotics under the 12 week study period
- Heavy nicotine users suggesting abstinence problems during the clamp
- Anti-coagulation with warfarin
- Ischemic heart disease with an event \< 6 months ago
- Inflammatory bowel disease
- Administration of antibiotics 4 weeks before inclusion
- Administration of probiotics 2 weeks before inclusion
- Participation in other clinical trials
- Other medical conditions, as judged by the screening doctor, that might jeopardize compliance to the protocol eg severe obesity interfering with access to peripheral veins
- Pregnancy
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01836796
Start Date
May 1 2012
End Date
July 1 2013
Last Update
October 25 2013
Active Locations (1)
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1
Clinical Trial Centre, Gröna Stråket 12, Sahlgrenska University Hospital
Gothenburg, Sweden, S-413 45