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 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:2018-08-26, 1397/06/04
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) and miRNA21,223 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)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available