Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201605262017N29
Enrollment
60
Registered
2016-12-18
Start date
2016-11-21
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes mellitus Type 2. Diabetes mellitus

Interventions

Intervention 1: Group 1 (intervention group) consume 6 capsules of 100 mg of sodium butyrate capsules and 5 mg starch powder as placebo for 6 weeks with meals daily. Intervention 2: Group 2 consume in
Treatment - Drugs
Group 1 (intervention group) consume 6 capsules of 100 mg of sodium butyrate capsules and 5 mg starch powder as placebo for 6 weeks with meals daily.
Group 2 consume inulin powder (chicory root extract) 10 g and 6 starch capsules 500 mg as placebo per day for 6 weeks.
Group 3 devoted to the concomitant use of inulin powder and capsules sodium butyrate (10 g inulin powder and sodium butyrate 6 capsules 100 mg) for 6 weeks.
Group 4 (control group) consume 6 capsules 500 mg starch as well as 5 mg starch powder as placebo for 6 weeks.

Sponsors

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

Eligibility

Sex/Gender
All
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: Major inclusion criteria included a diagnosis of type 2 diabetes; aged 30 to 50years; range 27 <BMI <35 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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Roshanravan

Tabriz university of Medical Sciences

roshanravann@tbzmed.ac.ir; neda.roshanravan10@gmail.com+98 41 3335 7581

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 27, 2026