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Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance (IRS-1/PI3K/Akt/mTOR/GLUT4) in adipose tissue of diabetic patients

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History
# Registration date Revision Id
2 2019-01-23, 1397/11/03 78379
1 2018-08-26, 1397/06/04 57423
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  • General information

    Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance (IRS-1/PI3K/Akt/mTOR/GLUT4) and miRNA21,223 in adipose tissue of diabetic patients
    Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance (IRS-1/PI3K/Akt/mTOR/GLUT4) in adipose tissue of diabetic patients
    اثر همزمانی متفورمین و سیتاگلیپتین بر میزان بیان پروتیئن های درگیر در مقاومت به انسولین (IRS-1/PI3K/Akt/mTOR/GLUT4) و miRNAهای 21 و 223 در بافت چربی بیماران دیابتی
    اثر همزمانی متفورمین و سیتاگلیپتین بر میزان بیان پروتیئن های درگیر در مقاومت به انسولین (IRS-1/PI3K/Akt/mTOR/GLUT4) در بافت چربی بیماران دیابتی

  • Sharing plan

    undecided
    yes
    undecided
    yes
    na
    yes
    undecided
    yes
    na
    yes
    na
    yes
    na
    yes
    Because this study is still not complete
    empty
    چون این مطالعه هنوز کامل نیست
    empty
    empty
    If individual data is available to participants without a first and last name, access to them is possible
    empty
    اگر داده فردی شرکت کنندگان بدون نام و نام خانوادگی باشد دسترسی به آنها ایرادی ندارد.
    empty
    forever
    empty
    برای همیشه
    empty
    All medical field researchers
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    تمام پژوهشگران حیطه پزشکی
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    Only for observation is allowed.
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    فقط برای مشاهده مجاز می باشد.
    empty
    Visit Iranian Randomized Clinical Trial
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    به مرکز کار آزمایی بالینی ایران مراجعه شود
    empty
    Users should certainly mention the name of the Iranian Randomized Clinical Trials as a source.
    empty
    استفاده کنندگان حتما باید نام مرکز کارآزمایی بالینی ایران را به عنوان منبع ذکر نمایند.

Protocol summary

Study aim
Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance IRS-1/PI3K/Akt/mTOR/GLUT4 and miRNA21,223 in adipose tissue of diabetic patients
Design
A form of informed consent and a questionnaire form filled in by me for the patient. Then, a blood sample of 10 ml of blood from each patient is taken prior to taking the medications for blood glucose tests and lipid profiles and insulin. After determining glucose and lipid profiles and insulin resistance, the resistance to insulin IR is determined by patients with HOMA-IR, and patients with an IR of 1.8-2 are included in the study. Patients are nonrandomized into two groups of 5, one 5-person group only metformin, and 5 others receive metformin and sitagliptin. Before taking the drug, patients with a surgeon will receive a sample of abdominal fat from each patient to test and determine the proteins of the insulin message transmission pathway by SDS PAGE elec. and Western Blot. After the treatment for three months, again, the same blood sample and abdominal fat samples are obtained from each patient, as before treatment, for the tests previously mentioned.
Settings and conduct
Yazd Diabetes Therapy, Research Center
Participants/Inclusion and exclusion criteria
Type 2 diabetics(New Case) insulin resistance are referred to the Yazd diabetes mellitus center. The maximum of 10 patients and 5 non-diabetic non-insulin-resistace subjects are selected as the control group.
Intervention groups
The first group of 5 patients received metformin alone. The second group is 5 patients receiving metformin and cyagliptin. 5 non-insulin-resistant non-diabetic subjects as control group
Main outcome variables
Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance IRS-1/PI3K/Akt/mTOR/GLUT4

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171018036870N2
Registration date: 2018-08-26, 1397/06/04
Registration timing: retrospective

Last update: 2019-02-06, 1397/11/17
Update count: 1
Registration date
2018-08-26, 1397/06/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 3417
Email address
didehdar@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-04, 1396/11/15
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance (IRS-1/PI3K/Akt/mTOR/GLUT4) in adipose tissue of diabetic patients
Public title
Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance in adipose tissue of diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes who have not yet taken medication and are recently diagnosed with a blood glucose test, the so-called New Case.
Exclusion criteria:
Diabetics who are taking medications, taking pills or taking insulin, have been eliminated.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of of Shahid Sadoughi Yazd University of Medical Sciences
Street address
Molecular Biology Dept. - Medical Faculty- Campus of Shahid Sadoughi University of Medical Sciences - Anonymous Martyrs Blvd- Professor Hesabi Blvd- Yazd
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2017-07-18, 1396/04/27
Ethics committee reference number
R.SSU.MEDICINE.REC.1396.54

Health conditions studied

1

Description of health condition studied
Type 2 Diabetes Mellitus
ICD-10 code
E11
ICD-10 code description
diabetes (mellitus)(nonobese)(obese): adult-onset maturity-onset nonketotic stable type II non-insulin-dependent diabetes of the young

Primary outcomes

1

Description
Combined metformin and sitagliptin effect on expression levels of proteins involved in insulin resistance IRS-1/PI3K/Akt/mTOR/GLUT4
Timepoint
Measuring the proteins involved in insulin resistance at the beginning of the study (before metformin and citagliptin therapy) and in 90 days (3 months) of drug use (after treatment with metformin and sitagliptin)
Method of measurement
How to measure these proteins using SDS-PAGE and Western blotting

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: We have two intervention groups: Group 1: This group only receive metformin for 3 months. Metformin: Branded metformin hexal, 500 mg (metformin hydrochloride), Made in Germany(Hexal AG), twice daily dosing, morning after breakfast, and evening after dinner.
Category
Diagnosis

2

Description
Intervention group: Group 2: This group receive metformin and sitaglyptin simultaneously for 3 months.Metformin: Branded metformin hexal, 500 mg (metformin hydrochloride), Made in Germany(Hexal AG), twice daily dosing, morning after breakfast, and evening after dinner. Sitaglyptin: Branded Januvia, 50mg manufactured by England, licensed to Merck, twice a day, in the morning after breakfast and at night after dinner.
Category
Diagnosis

3

Description
Control group: 5 non-immune non-insulin-dependent non-insulin-dependent individuals. These people do not use any drugs.
Category
Diagnosis

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Diabetes Therapy, Research Center
Full name of responsible person
Mr. Dr. Massoud Rahmanian
Street address
Diabetes Therapy, Research Center- Alley of Art Hall- Beginning of Bahonar Sq. to Azadi Sq.- Shahid Sadoughi Blvd- Yazd
City
Yazd
Province
Yazd
Postal code
8917693586
Phone
+98 35 3728 0226
Email
Rahmanian@ssu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. AmirHoushang Mehrparvar
Street address
Third Floor- Shahid Sadoughi University of Medical Sciences and Health Services Yazd- Bahonar Sq. -Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3724 0171
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
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
Yazd University of Medical Sciences
Full name of responsible person
Reza Didehdar
Position
Ph.D. student of clinical biochemistry
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Yazd-Boulevard, PrMolecular Biology and Biochemistry Dpt.- Medical Faculty- Medical Sciences Pardis- Anonymous Martyrs Bivd- Professor Hassabi-Blvd- Yazd
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3417
Email
didehdar@zbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reza Didehdar
Position
Clinical Biochemistry PhD student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Biochemistry and Molecular Biology Dept.- Faculty of Medicine- Campus of Meical Sciences University- Anonymous Martyrs Blvd- Professor Hassabi Blvd- Yazd
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
didehdar@zbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Reza Didehdar
Position
29/5000 Clinical Biochemistry PhD student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
Biochemistry and Molecular Biology Dept.- Faculty of Medicine- Campus of Medical Sciences University Anonymous Martyrs Blvd- Professor Hassabi Blvd- Yazd
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
didehdar@zbmu.ac.ir

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
If individual data is available to participants without a first and last name, access to them is possible
When the data will become available and for how long
forever
To whom data/document is available
All medical field researchers
Under which criteria data/document could be used
Only for observation is allowed.
From where data/document is obtainable
Visit Iranian Randomized Clinical Trial
What processes are involved for a request to access data/document
Users should certainly mention the name of the Iranian Randomized Clinical Trials as a source.
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