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
This study will be done with the aim of investigating 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.
Design
In this double-blind randomized placebo-controlled parallel group clinical trial, 42 type 2 diabetic patients of both sexes will be randomly divided into 2 groups of 21 individuals.
Settings and conduct
The study will be conducted in the Nutrition Research Center of Tabriz University of Medical Sciences.Patients will be randomly assigned into 2 groups. The questionnaires of general information will be completed. After random allocation each patient will receive proprietary supplement for 6 weeks. Sodium butyrate and placebo packs will be encoded by the person responsible for preparation؛ investigators and patients will be blinded to the type of the supplement each group receives. Fasting blood samples will be collected at baseline and at the end of the study.
Participants/Inclusion and exclusion criteria
Major eligibility criteria: Ages between 30 to 50 years; Diagnosis of type 2 diabetes; BMI between 27 to 35 kg/m2. Exclusion criteria: chronic diseases; Kidney, liver and thyroid disorders; Rheumatic Diseases; Inflammatory diseases; Insulin injection, taking estrogenic drugs, progesterone & corticosteroids; Taking supplements, and antibiotics; Smoking; Pregnancy; lactation; menopause;
Intervention groups
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 food. Group 2, as a control group, will use 6 starch capsules daily as placebo.
Main outcome variables
Glycemic indexes; lipid profile; expression of TLR-4, NLRP3, ASC, Caspase-1, IL-1β, IL-18; glutathione peroxidase(GPx); Nitric oxide(NO) will be evaluated before and after the supplementation.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090609002017N33
Registration date:2019-04-06, 1398/01/17
Registration timing:registered_while_recruiting
Last update:2019-04-06, 1398/01/17
Update count:0
Registration date
2019-04-06, 1398/01/17
Registrant information
Name
Alireza Ostadrahimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
ostadrahimi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-25, 1398/01/05
Expected recruitment end date
2019-05-15, 1398/02/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effect of sodium butyrate in prevention and treatment of type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be assigned to intervention and control groups by random blocking.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, investigator and participants will be unaware of the type of supplementation (sodium butyrate or placebo).The person responsible for the preparation of capsules' packs (a person completely unrelated to the study) will be asked to assign a code to each of the two packages (sodium butyrate and placebo), and to keep the codes up to the end of the study and data analysis.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
3rd. Floor, Central Bldg. No.2, Golgasht st., Azadi Ave.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutrition Research Center, Tabriz University of Medical Science
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Khosravi
Position
MSc student in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition, Tabriz University of Medical Science, Attar Neyshaburi st., Golgasht ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
z.khosravi71@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition, Tabriz University of Medical Science, Attar Neyshaburi st., Golgasht ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2295
Email
ostadrahimi@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zeinab Khosravi
Position
MSc student in Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition, Tabriz University of Medical Science, Attar Neyshaburi st., Golgasht ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7580
Email
z.khosravi71@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Individual participant data that underlie the outcomes reported in this article, after deidentification (text, tables, figures, and appendices),Study Protocol, Statistical Analysis Plan, Clinical Study Report
When the data will become available and for how long
Beginning 6 months and ending 2 years following article publication
To whom data/document is available
Researchers who provide a methodologically sound proposal.
Under which criteria data/document could be used
The datasets are available from the corresponding author on reasonable request and to achieve aims in the approved proposal.
From where data/document is obtainable
Proposals should be directed to corresponding author.
What processes are involved for a request to access data/document
All data requests should be submitted to the corresponding author for consideration. To gain access, data requestors will need to sign a data access agreement.