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

Phase 2

Conditions: Diabetes mellitus Type 2.
Diabetes mellitus
E10, E11,

Registration Number: IRCT201605262017N29

Lead Sponsor: Vice-Chancellor for Research of Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 60

Inclusion Criteria

Major inclusion criteria included a diagnosis of type 2 diabetes; aged 30 to 50years; range 27 Major exclusion criteria included: kidney problems; liver failure; heart failure; rheumatic diseases and inflammatory diseases of the gastrointestinal tract; insulin injections and drugs; estrogen; progesterone ; taking vitamin supplements; minerals; omega-3 and antibiotics for three weeks before the study

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Txnip Gene. Timepoint: Before & after intervention. Method of measurement: Real-time PCR.;Level of GLP-1. Timepoint: Before & after intervention. Method of measurement: Elisa test.;Levels of mir-204. Timepoint: Before & after intervention. Method of measurement: Real-time PCR.;Levels of mir-200c. Timepoint: Before & after intervention. Method of measurement: Real-time PCR.;Levels of mir-21. Timepoint: Before & after intervention. Method of measurement: Real-time PCR.

Secondary Outcome Measures

Name	Time	Method
Fasting blood glucose. Timepoint: before & after intervention. Method of measurement: Enzymatic assay.;Blood sugar 2 hpp. Timepoint: before & after intervention. Method of measurement: Enzymatic assay.;Fasting Insulin. Timepoint: before & after intervention. Method of measurement: Elisa.;HbA1C. Timepoint: before & after intervention. Method of measurement: Kit.;Lipid profile. Timepoint: before & after intervention. Method of measurement: Enzymatic assay.;Energy and macronutrients. Timepoint: before & after intervention. Method of measurement: 3 days recall.;Abundance of Akkermansia muciniphila bacteria in stool samples. Timepoint: before & after intervention. Method of measurement: colony count.