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Effect of probiotic supplements on patients with type 2 diabetes

Phase 2
Conditions
Type 2 Diabetes.
Non-insulin-dependent diabetes mellitus
Registration Number
IRCT2013100714925N1
Lead Sponsor
Vice chancellor of Shahid Beheshti Endocrinology Research center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
60
Inclusion Criteria

Having type 2 diabetes mellitus; the age range was 25 to 65 years with a fifteen-year maximal period of type 2 diabetes mellitus ; controlled glucose and lipid levels of the patients were considered ; taking drugs prescribed by doctors were permitted until their dosages were unchanged during the intervention. Exclusion criteria: Having replacement treatments like Hormone or supplemental vitamins ; tobacco and alcohol use ; clinical signs of chronic kidney, liver or pulmonary disease ; chronic or acute inflammatory disease (especially acute pancreatic inflammation and Endocarditis) ; heart valve disease ; short bowel syndrome ; allergies ; immunosuppressives ; pregnancy and lactation and taking less than 10% of probiotic or placebo supplements.

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fasting Blood Sugar. Timepoint: Baseline, and after 6 weeks. Method of measurement: Biochemical Analysis.;Serum Insulin. Timepoint: Baseline and after 6 weeks. Method of measurement: ELIZA.;HOMA-IR. Timepoint: Baseline and after 6 weeks. Method of measurement: Formula.;Lipid profile: Total cholesterol, Triglyceride, HDL-C, LDL-C. Timepoint: Baseline and after 6 weeks. Method of measurement: Biochemical Analysis.
Secondary Outcome Measures
NameTimeMethod
Dietary Factors. Timepoint: Baseline and after 6 weeks. Method of measurement: 24 hour and 3-day dietary Recall.;Body Mass Index. Timepoint: Baseline and after 6 weeks. Method of measurement: Formula.;Waist Circumference. Timepoint: Baseline and after 6 weeks. Method of measurement: Inelastic Plastic Tape.;Hip Circumference. Timepoint: Baseline and after 6 weeks. Method of measurement: Inelastic Plastic Tape.;Waist to Hip Ratio. Timepoint: Baseline and after 6 weeks. Method of measurement: Formula.
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