(1) Objectives: The effect of sodium butyrate and inulin supplementation solo and simultaneously on glycemic index, Txnip gene expression and circulating levels of GLP-1, miR-204, miR-200c and miR-21 in patients with type 2 diabetes
(2) Design: In this clinical trail, 60 patients with type 2 diabetic patients will be selected and randomly divided into 4 groups of 15 individuals.
(3) Setting and conduct: After random allocation each patient will receive proprietary supplement for 45 days.
(4) Participants including major eligibility criteria:
Inclusion criteria included a diagnosis of type 2 diabetes; aged 30 to 50years; 27 <BMI range<35
Exclusion criteria included: kidney problems; liver failure, heart failure; rheumatic diseases and inflammatory diseases of the gastrointestinal tract; insulin injections and drugs; estrogen; progesterone; corticosteroids; smoking; breast feeding and pregnancy; taking vitamin supplements; minerals; omega-3 and antibiotics for three weeks before the study.
(5) Intervention: Group 1 will receive sodium butyrate capsules (BodyBio) for 6 weeks as intervention drug as well as 5mg starch powder as placebo . Group 2 will consume inulin powder in the amount of 10 grams per day divided into two meals daily and 6 capsules 500 mg of starch as placebo. Group 3 devoted to the concomitant use of inulin powder and sodium butyrate capsules and Group 4 as the control group will receive placebo in the form of cap and powder.
(6) main outcome measures (variables): Before and after the intervention of all participants will be received stool and blood samples. Frequency of Akkermansia muciniphila bacteria in stool before and after supplementation, serum levels of fasting glucose, insulin, HbA1C index, blood sugar levels after two hours eating breakfast, as well as the Txnip (Thioredoxin-interacting protein) gene expression and plasma levels of GLP-1( Glucagone like peptide 1), miR-204, miR-200c and miR-21 in all patients before and after supplementation will be evaluated.