Study on the comprasion of the effect of oligofructose-enriched inulin with maltodextrin (placebo) on some immunologic,inflammatory and anti-inflammatory factors in type 2 diabetes
This randomized double blind clinical trial is designed with the goal of determining the effect of oligofructose-enriched inulin with maltodextrin on some immunologic,inflammatory and anti-inflammatory factors in type 2 diabetes.44 patients with type 2 diabetes between the age range of 30-65 have at least 6-month history of diabetes and oral drugs lower blood sugar using and do not have liver,renal and heart diseases,will divided randomly to two groups of 22 people into experimental or control groups with the use of the software RAS and in the form of block 6cases . The patients in the intervention group will receive 10 g Oligofructose-enriched inulin powder /d for two months while those in the control group will receive 10g dextrin maltose/d for two months. Daily supplements will be divided into 2 portions of 5g each to be eaten during breakfast and dinner. The immunologic, inflammatory and anti-inflammatory factors will be measured before and after the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203103565N4
Registration date:2012-03-27, 1391/01/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-27, 1391/01/08
Registrant information
Name
Akbar Aliasgarzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
asgharzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Vice Chancellor Of Tabriz University Of Medical Sciences
Expected recruitment start date
2012-02-22, 1390/12/03
Expected recruitment end date
2012-06-23, 1391/04/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the comprasion of the effect of oligofructose-enriched inulin with maltodextrin (placebo) on some immunologic,inflammatory and anti-inflammatory factors in type 2 diabetes
Public title
Study on the effect of oligofructose-enriched inulin in type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 30-65 years old, having diabetes at least 6 months prior to the study, consumption of blood glucose lowering drug,. typical fiber intake <25 g fiber/d and inulin fructans intake ≤200 g fiber/d.
Exclusion criteria: consumption of antioxidants supplements during last 3 months prior to the study, using insulin, pregnancy, lactation, acute renal disease,liver disease,hyperthyroidism and hypothyroidism,heart disease
Age
From 30 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee Of Tabriz University Of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Tabriz, Iran
City
Tabriz
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
9093
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
CD4/CD8،CD3،CD4،CD8،CD11b
Timepoint
Baseline,The end of the second month
Method of measurement
Flow cytometry
2
Description
IFN-γ,IL12
Timepoint
Baseline,The end of the second month
Method of measurement
Elisa
3
Description
IL4
Timepoint
Baseline,The end of the second month
Method of measurement
Elisa
Secondary outcomes
1
Description
weight,height,BMI,WHR,WC
Timepoint
Baseline,The end of second month
Method of measurement
Antropometric Methods
2
Description
TC،TG،HDL،LDL
Timepoint
Baseline,The end of second month
Method of measurement
calorimetric
3
Description
FBS,HbA1C
Timepoint
Baseline,The end of second month
Method of measurement
calorimetric
4
Description
Blood pressure
Timepoint
Baseline,The end of second month
Method of measurement
Mercury pressure measurement
Intervention groups
1
Description
Intervention group: Oligofructose-enriched inulin powder 10 g /d, divided into 2 portions of 5g each to be eaten during breakfast and dinner, for two months
Category
Treatment - Drugs
2
Description
Control group: dextrin maltose 10 g /d, divided into 2 portions of 5g each to be eaten during breakfast and dinner, for two months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Atiyeh Clinic
Full name of responsible person
Dr Akbar Ali Asgharzadeh
Street address
Atiyeh Clinic, Maralan Square, Azadi Street, Tabriz, East Azarbayjan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty Of Medicine, Tabriz University Of Medical Sciences
Full name of responsible person
Dr Akbar Ali Asgharzadeh
Street address
Faculty Of Medicine, Tabriz University Of Medical Sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty Of Medicine, 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
Faculty Of Medicine, Tabriz University Of Medical Sciences
Full name of responsible person
Dr Farnaz Tavakkoli
Position
Assistant Professional Internal Diseases
Other areas of specialty/work
Street address
Faculty Of Medicine, Tabriz University Of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 4667
Fax
Email
farnaz_tavakkoli62@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty Of Medicine, Tabriz University Of Medical Sciences
Full name of responsible person
Dr Akbar Ali Asgharzadeh
Position
Professor, Educational Assistant Section Of Endocrinology
Other areas of specialty/work
Street address
Emamreza Hospital, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1337 3966
Fax
Email
asgharzadeha@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty Of Medicine, Tabriz University Of Medical Sciences
Full name of responsible person
Dr Farnaz Tavakkoli
Position
Assistant Professional Internal Diseases
Other areas of specialty/work
Street address
Faculty Of Medicine, Tabriz University Of Medical Sciences, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1336 4667
Fax
Email
farnaz_tavakkoli62@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)