Pro-biotic on inflammation factors in patients with type 2 diabetes mellitus
Phase 2
- Conditions
- Type II diabetes mellitus.Non-insulin-dependent diabetes mellitus
- Registration Number
- IRCT2014110519816N1
- Lead Sponsor
- Sabzevar University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
patients affected to diabetes melitus type 2; body mass index <35 kg/m2; patients enrolled in this study should have no infectious disease, hepatitis or renal diseases.
Exclusion criteria: patients received cholesterol-lowering drugs, probiotic, prebiotic and omega-3 fatty acids and antibiotics from 1 month before and during the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Inflammation factors (CRP, IL-6 and TNF). Timepoint: Baseline (before initiating intervention) and 8 weeks after initiating intervention. Method of measurement: Enzyme-like immune- sorbent assay (ELISA) kits (Monobind, Inc., Lake Forest, Calif., USA).
- Secondary Outcome Measures
Name Time Method Serum lipid profile (LDL, HDL, total). Timepoint: Baseline and the end of week 8. Method of measurement: Kits of Pars Test company and Auto analyzer Selectra 2 methods.