Type 2 diabetes mellitus. Type 2 diabetes mellitus
Conditions
Interventions
Intervention 1: Intervention group: Intervention group: The intervention group will receive synbiotic capsules (containing probiotic, fructo-oligosaccharide as prebiotic, lactose, magnesium stearate,
Sponsors
Yazd Diabetes Research Center
Yazd University of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
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
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 or treatment with antibiotics within the past month Follow the unusual diet up to 1month before the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFahime Zeinali
Yazd Diabetes Research Center
Outcome results
None listed