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Effect of sodium butyrate in prevention and treatment of type 2 diabetes

The effect of sodium butyrate supplementation on serum oxidative stress indices and gene expression level of pyroptosis related inflammatory factors in type 2 diabetic patients: A randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20090609002017N33
Enrollment
42
Registered
2019-04-06
Start date
2019-03-25
Completion date
Unknown
Last updated
2019-04-23

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

Interventions

Intervention 1: Group 1 will receive sodium butyrate capsules (BodyBio) for 6 weeks at a daily dose of 600 mg in the form of capsules of 100 mg with meals. Intervention 2: Control group: Group 2 will

Sponsors

Nutrition Research Center, Tabriz University of Medical Science
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: Willingness to participate in the study Ages between 30 to 50 years (both sexes) Diagnosis of type 2 diabetes Body mass index (BMI) between 27 to 35 kg/m2 People who control their diabetes just by using blood glucose lowering tablets.

Exclusion criteria

Exclusion criteria: Unwillingness to participate in the study Chronic diseases such as cardiovascular disorders and ... Kidney, liver and thyroid disorders Rheumatic Diseases Inflammatory diseases of the gastrointestinal tract or malabsorption, such as sprue and crowns Insulin injection, taking estrogenic drugs, progesterone & corticosteroids Taking vitamin supplements; minerals; omega-3 and antibiotics for three weeks before the study Changes in diet and physical activity Smoking Having certain physiological conditions like pregnancy and lactation and menopause

Design outcomes

Primary

MeasureTime frame
TLR-4 expression. Timepoint: Before & after the intervention. Method of measurement: Real-time PCR.;NLRP3 expression. Timepoint: Before & after the intervention. Method of measurement: Real-time PCR.;Caspase-1 expression. Timepoint: Before & after the intervention. Method of measurement: Real-time PCR.;ASC expression. Timepoint: Before & after the intervention. Method of measurement: Real-time PCR.;IL-1ß expression. Timepoint: Before & after the intervention. Method of measurement: Real-time PCR.;IL-18 expression. Timepoint: Before & after the intervention. Method of measurement: Real-time PCR.;Glutathion Peroxidase (GPx). Timepoint: Before & after the intervention. Method of measurement: Kit.;Nitric Oxide (NO). Timepoint: Before & after the intervention. Method of measurement: Kit.;Fasting Blood Glucose. Timepoint: Before & after the intervention. Method of measurement: Enzymatic assay.;Fasting Insulin. Timepoint: Before & after the intervention. Method of measurement: ELISA.;HbA1c. Timepoint: Before & after the intervention. Method of measurement: Kit.;HOMA-IR. Timepoint: Before & after the intervention. Method of measurement: HOMA-IR formula: [fasting insulin (µU/ml)*fasting glucose (mg/dL)]/ 405.;Triglyceride. Timepoint: Before & after the intervention. Method of measurement: Enzymatic method.;HDL-Cholesterol. Timepoint: Before & after the intervention. Method of measurement: Enzymatic method.;Total Cholesterol. Timepoint: Before & after the intervention. Method of measurement: Enzymatic method.;LDL-Cholesterol. Timepoint: Before & after the intervention. Method of measurement: Friedewald's formula: LDL= TC - [HDL + (TG/5)].

Secondary

MeasureTime frame
Systolic Blood Pressure. Timepoint: Before & after the intervention. Method of measurement: Digital barometer.;Diastolic Blood Pressure. Timepoint: Before & after the intervention. Method of measurement: Digital barometer.;Energy and macro-nutrient intake. Timepoint: Before & after the intervention. Method of measurement: Questionnaire (3 days dietary record).;Weight. Timepoint: Before & after the intervention. Method of measurement: scale.;Body Mass Index. Timepoint: Before & after the intervention. Method of measurement: BMI formula.;Waist circumference. Timepoint: Before & after the intervention. Method of measurement: Nonelastic flexible tape.;Hip circumferences. Timepoint: Before & after the intervention. Method of measurement: Nonelastic flexible tape.;Waist to Hip Ratio (WHR). Timepoint: Before & after the intervention. Method of measurement: Calculation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZeinab Khosravi

Tabriz University of Medical Sciences

z.khosravi71@yahoo.com+98 41 3335 7580

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026