The effect of Inullin supplementation on expression of KLF5 in Peripheral Blood Mononuclear Cell and pelasma levels miR-375 in patients with type 2 diabetes
This study with The aim of inulin supplementation effect on KLF5(Krüppel-like factor 5) expression in mononuclear cells and plasma levels of miR-375 on 46 patients with type 2 diabetes that patients randomly divided into two groups of 23 .The first group (intervention) will be adminestrated with 10 g per day of inullin powder divided two portions accompanied by main meals for 6 weeks. And the control group will be adminestrated with 10 g per day placebo (corn starch) divided two portions accompanied by main meals for 6 week.All patients will be selected of Rohzende2 health care center in Shabestar.inclusion criteria for this study include:The diagnosis of type 2 diabetes; Aged 30 to 50 years; body mass index greater than 25 and less than 35 and Exclusion criteria include: kidney disease; liver failure; heart failure; rheumatic diseases inflammatory diseases of the gastrointestinal tract; lactose intolerance; insulin injection and drugs Consumption: estrogen, progesterone, corticosteroids; smoking; breast feeding and pregnancy; vitamin, minerals,omega-3 and antibiotics supplementation for three weeks before the start of the study will be considered.Before and after treatment from all of participants blood samples will be taken.And the expression of KLF5 and mir-375 all patients before and after supplementation will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201610212017N31
Registration date:2016-12-19, 1395/09/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-19, 1395/09/29
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
vice-chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-09-19, 1395/06/29
Expected recruitment end date
2018-09-20, 1397/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Inullin supplementation on expression of KLF5 in Peripheral Blood Mononuclear Cell and pelasma levels miR-375 in patients with type 2 diabetes
Public title
The effect of Inullin supplementation on expression of KLF5 in Peripheral Blood Mononuclear Cell and pelasma levels miR-375 in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria included:The diagnosis of type2 diabetes; aged 30 to 50 years; body mass index greater than 25 and less than 35
Exclusion criteria included: kidney disease; liver failure; heart failure; rheumatic diseases inflammatory diseases of the gastrointestinal tract; lactose intolerance; insulin injection and drugs Consumption: estrogen, progesterone, corticosteroids; smoking; breast feeding and pregnancy; vitamin, minerals,omega-3 and antibiotics supplementation for three weeks before the start of the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
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
Third Floor, Central Building(2), Tabriz University of Medical Sciences, Golgasht Street Tabriz
City
Tabriz
Postal code
00984133344280
Approval date
2016-09-26, 1395/07/05
Ethics committee reference number
IR.TBZMED.REC.1395.671
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E11
ICD-10 code description
Non-Insulin Dependent Diabetes Mellitus
Primary outcomes
1
Description
Mir-375
Timepoint
Befor and After
Method of measurement
Real-Time
Secondary outcomes
1
Description
KLF5
Timepoint
Before and After
Method of measurement
Real-Time
Intervention groups
1
Description
Intervention Groups: Two Oral Dose of 5 g of Inulin
Category
Treatment - Other
2
Description
Control group: Two Oral Dose 5 g Starch Corn
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Healt Center Rvhzndh 2
Full name of responsible person
Neda Roshanravan
Street address
Imam Khomeini Avenue, Shabestar,Tabriz
City
Shabestar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Street address
East Azarbaijan
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Supervisor
Other areas of specialty/work
Street address
Tabriz,
City
Tabriz
Postal code
5165995131
Phone
+98 41 3337 9003
Fax
Email
aostadrahimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Proffesor
Other areas of specialty/work
Street address
Tabriz, East Azarbaijan
City
Tabriz
Postal code
00984133357584
Phone
+98 41 3335 7580
Fax
Email
aostadrahimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostadrahimi
Position
Proffesor
Other areas of specialty/work
Street address
Tabriz, East Azarbaijan
City
Tabriz
Postal code
00984133357580
Phone
+98 41 3335 7584
Fax
Email
aostadrahimi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)