Determining the effects of sitagliptin on inflammatory factors, renal and pancreatic function and cognitive activity in type 2 diabetics.
Design
A double-blind clinical trial with a parallel control group on 60 type 2 diabetic patients who will be randomly assigned to two groups. The two groups of type 2 diabetics will include the control group (those treated with metformin alone) and the intervention group (those treated with metformin and sitagliptin). Medications for both groups of patients are prescribed by the treating physician.
Settings and conduct
This study will be performed in medical centers of Semnan University of Medical Sciences. Blood and urine samples will be taken from all patients at the beginning and end of the study. Treatment of both groups will be done under the supervision of the treating physician. The patient, the patient's clinical caregiver, and the analyzer of the final results will be unaware of the grouping and allocation of drugs. But the treating physician and project manager will be aware of the medications and groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All type 2 diabetic patients; Having the informed consent; between 35 and 65 years; Healthy physical conditions; No history of taking DPP-4 inhibitors; Not being pregnant for women
Exclusion criteria: history of malignancy, AIDS, hepatitis; acute psychologic diseases; Severe kidney disorder and cardiovascular problems.
Intervention groups
Type 2 diabetic patients treated with metformin alone (as control group) or metformin + sitagliptin (as intervention group)
The Effect of Sitagliptin on Plasma Metabolic Factors, Cognitive Activities, Renal and Pancreatic Functions in Type 2 Diabetic Patients of Semnan city
Public title
The Effects of Sitagliptin on Type 2 Diabetic Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes mellitus
Healthy physical conditions
No history of taking DPP-4 inhibitors
Not being pregnant for women
informed consent to participate in the study
Exclusion criteria:
A history of malignancy or diseases such as AIDS or hepatitis
A history of acute psychological diseases
Severe renal dysfunction
cardiovascular disorders
Age
From 20 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participating patient , the clinical caregiver (who is a nurse), and the epidemiologist who analyzing the final results are blind. But the treating physician and plan supervisor are aware of medications and groups.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Semnan University of Medical Sciences
Street address
Basij Boulvared
City
Semnan
Province
Semnan
Postal code
35147-99442
Approval date
2020-09-22, 1399/07/01
Ethics committee reference number
IR.SEMUMS.REC.1399.186
Health conditions studied
1
Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Decreased fasting blood glucose
Timepoint
Before and after the intervention
Method of measurement
Biochemical-laboratory method
2
Description
Improvement of plasma lipid profiles
Timepoint
Before and after the intervention
Method of measurement
Biochemical-laboratory method
3
Description
Improvement of cognitive functions
Timepoint
Before and after the intervention
Method of measurement
wechsler tool
4
Description
improvement in renal function
Timepoint
Before and after the intervention
Method of measurement
Biochemical-laboratory method
5
Description
improve in pancreatic efficiency
Timepoint
Before and after the intervention
Method of measurement
Biochemical-laboratory method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Type 2 diabetic patients treated with metformin + DPP-4 inhibitor (Sitagliptin). These patients will be selected from the people referring to Semnan Diabetes Clinic and will take the desired drug orally for 90 days with a dose of 100 mg of sitagliptin and 2000 mg of metformin. This medication will be performed with a drug made by Abidi Pharmaceutical Company and under the supervision of the treating physician.
Category
Treatment - Drugs
2
Description
Control group: Type 2 diabetic patients treated with metformin. These patients will be selected from the people referring to the Diabetes Clinic of Semnan and will take the desired drug orally for 90 days at a dose of 2000 mg of metformin. This medication will be performed with a drug made by Abidi Pharmaceutical Company and under the supervision of the treating physician.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital Diabetes Clinic
Full name of responsible person
Habib Yaribeygi
Street address
Basij
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Email
kosarhos@semums.ac.ir
Web page address
https://kosarhos.semums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Abidi pharmacy
Full name of responsible person
Dr. Seyed Amir Razavian Ardehali
Street address
8 km of Karaj special road, Dr. Obidi Boulevard
City
Tehran
Province
Tehran
Postal code
۷۶۳۶۳ - ۱۳۸۹۷
Phone
+98 21 4450 4787
Email
dr.soorena@gmail.com
Web page address
https://abidipharma.com/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Abidi pharmacy
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Habib Yaribeygi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Basij
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4170
Email
habib.yari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Habib Yaribeygi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Basij
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4170
Email
habib.yari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Majid Mirmohammadkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Basij
City
Semnan
Province
Semnan
Postal code
35147-99442
Phone
+98 23 3365 4170
Email
majidmirmohammadkhani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
it has no ethical approve.
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the data will be published in the form of a project report and article.
When the data will become available and for how long
Raw data will not be published. But the final results will be published in the form of reports and articles about 6 months after the end of the project.
To whom data/document is available
Everyone can read the final report and the resulting article.
Under which criteria data/document could be used
Only for writing the final report and article
From where data/document is obtainable
Physiology Research Center of Semnan University of Medical Sciences
What processes are involved for a request to access data/document
Raw data will not be published (due to ethical issues)