Synbiotic and gut microbiome
- Conditions
- Type 2 diabetes mellitus.Type 2 diabetes mellitus
- Registration Number
- IRCT20180624040228N2
- Lead Sponsor
- Yazd Diabetes Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
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
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 or treatment with antibiotics within the past month
Follow the unusual diet up to 1month before the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gut microbiom. Timepoint: Before and immediately after the intervention. Method of measurement: Quantitative Real time Polymerase Chain Reaction (QPCR) and 16s rRNA sequencing.;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 tumor necrosis factor alpha. Timepoint: Before and immediately after the intervention. Method of measurement: ELISA kit.
- Secondary Outcome Measures
Name Time Method 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.