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synbiotic in diabetes

Phase 3
Conditions
Type 2 diabetes mellitus
Type 2 diabetes mellitus.
Registration Number
IRCT20180624040228N1
Lead Sponsor
Yazd University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
72
Inclusion Criteria

Men and women with type 2 diabetes (the minimum elapsed time of diagnosis is 3 months and diabetes treatment is started in person)
Age range 25 to 65 years
Glycosylated hemoglobin above 6.5% and below 8.5%
BMI is between 25 and 35

Exclusion Criteria

Using alternative therapies with hormone (Insulin, Corticosteroids) or vitamin supplements
Chronic kidney, liver, pulmonary diseases. chronic or acute inflammatory diseases (especially acute Pancreatic inflammation and Endocarditis)
Valvular disease of the heart. Irritable Bowel Syndrome. Allergic
Diabetes complications (Nephropathy, Cardiomyopathy, Retinopathy, Diabetic foot ulcers)
People with low immune system (Autoimmune)
Pregnancy, Lactation
Use of tobacco and alcohol
Probiotic consumption in the last three months
Follow the unusual diet up to 1month before the study

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Expression of microRNA-126. Timepoint: Before and immediately after the intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR).;Experation of microRNA-146a. Timepoint: Before and immediately after the intervention. Method of measurement: Real time Polymerase Chain Reaction (PCR).;Serum levels of interleukin 6. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.;Serum levels of tumor necrosis factor alpha. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.;Serum levels of Malondialdehyde. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.;Serum levels of total antioxidant capacity. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.
Secondary Outcome Measures
NameTimeMethod
Triglyceride. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;Total cholesterol. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;High-density lipoprotein. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;Low-density lipoprotein. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;Fasting Blood Sugar. Timepoint: Before and immediately after the intervention. Method of measurement: Turbidity test.;Glycosylated hemoglobin. Timepoint: Before and immediately after the intervention. Method of measurement: Enzymatic Assay Kit.;Fasting insulin. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.
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