Synchronization of metformin with sitagliptin on the expression of` miRNA21, 223 in insulin resistant human adipocyte tissue and serum
Design
The first phase: selection of two groups of fat persons with insulin resistant(BMI>35) and non fat(normal BMI)without insulin resistant and take serum and adipose tissue and determination of level of miRNAs expression with RT_PCR method and compare with together.
The second phase: selection of fat person to two groups: one for treat with metformin , and other for treat with metformin and sitagliptin for 2-3 months, than take serum and adipose tissue and determination of level of miRNAs synthesis with RT_PCR method and compare with together.
Settings and conduct
Diabetic Reaserch Center
Participants/Inclusion and exclusion criteria
Selection and entrance conditions: Everybody with diagnosis as diabetic for the first time and new case, and if have HOMA index more than 1.5 are case group and less than 1.5 are control group.Between groups was assimilated in age, sex and some variables.
Exit condition: Everybody had diabetes, used to diabetic drugs or insulin injection.Person with hormone therapy or endocrine disorders.Person with renal disorders and cancer or malignant tumors and chemotherapy, are exited from survey.
Intervention groups
Persons that were reffered to Diabetes Center of Yazd and are diabetic for the first time selected and thay were fat (BMI more than 30) and insulin resistant selected for determination of level of miRNA expression in serum and adipo-tissue and compare with person that are not insulin resistant with normal BMI.Than drug interferences is performed and repeat level of miRNA expression in serum and adipose tissue.
Main outcome variables
Age
Sex
Weight
Height
BMI
Insulin resistant
miRNA
Insulin
FBS
TG
Cholestrol
MiRNA changes
Metformin
Sitagliptin
Treatment group
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180408039225N1
Registration date:2018-06-02, 1397/03/12
Registration timing:registered_while_recruiting
Last update:2018-06-02, 1397/03/12
Update count:0
Registration date
2018-06-02, 1397/03/12
Registrant information
Name
Yousof Naghiaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3728 0215
Email address
yosofnaghiaee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-09-22, 1397/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Synchronization of metformin with sitagliptin on the expression of` miRNA21, 223 in insulin resistant human adipocyte tissue and serum
Public title
Synchronization of metformin with sitagliptin on the expression of` miRNA21, 223 in insulin resistant human adipocyte tissue and serum
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Everybody as diabetic for the first time and new case was selected, and if have HOMA index more than 1.5 are case group and less than 1.5 are control group.
Exclusion criteria:
Everybody as diabetic or used to diabetic drugs or insulin and everybody had hormone therapy or with endocrine disorders, persons with renal disorders and cancer or malignant tumors and had chemotherapy are deleted from survey.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Moral in Biomedical Researches
Street address
Bahonar square_Central Organization of Shahid Sadughi University
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.SSU.REC.1396.40
Health conditions studied
1
Description of health condition studied
Insulin resistance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
MiRNA changes
Timepoint
First -End
Method of measurement
RT_PCR method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fat persons with insulin resistance. Division to two groups: one for treat with metformin , and other for treat with metformin and sitagliptin for 2-3 months, than take serum and adipose tissue and determination of level of miRNAs expression with RT_PCR method and compare with together.
Category
Diagnosis
2
Description
Control group: Non fat person without insulin resistance without consumption of drug and take serum and adipose tissue and determination of level of miRNAs expression with RT_PCR method.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center of diabetes
Full name of responsible person
Naghiaee,Yousof
Street address
Bahonar square_Research center of diabetes
City
Yazd
Province
Yazd
Postal code
8917693571
Phone
+98 35 3728 0215
Email
yosofnaghiaee@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Mehrparvar,Amir Hoshang
Street address
Bahonar square_central organization of shahid Sadoughi university
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3146 2146
Email
ah.mehrparvar@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
40
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
Yazd University of Medical Sciences
Full name of responsible person
Naghiaee,Yousof
Position
Employee
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Emam hossein square_Emam Reza complex
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3168 2105
Email
yosofnaghiaee@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Naghiaee,Yousof
Position
Employee
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Emam Hosein square_Emam Reza complex
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3168 2105
Email
yosofnaghiaee@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Naghiaee,Yousof
Position
Employee
Latest degree
Ph.D.
Other areas of specialty/work
Biochemistry
Street address
Emam Hosein square_Emam Reza complex
City
Yazd
Province
Yazd
Postal code
8916188637
Phone
+98 35 3168 2105
Email
yosofnaghiaee@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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
synchronization of metformin with sitagliptin on the expression of` miRNA21,223 in insulin resistant human adipocyte tissue and serum
When the data will become available and for how long
there is not time period
To whom data/document is available
everybody
Under which criteria data/document could be used
in diabetes researchs
From where data/document is obtainable
in e-mail address:yosofnaghiaee@yahoo.com
What processes are involved for a request to access data/document