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Trial registered on ANZCTR


Registration number
ACTRN12624001135505
Ethics application status
Approved
Date submitted
13/07/2024
Date registered
20/09/2024
Date last updated
20/09/2024
Date data sharing statement initially provided
20/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relationship of serological levels for death receptors
(TNFR1, TRAIL -R2, FAS ) With early pancreatic ß cell Apoptosis and Follow up after DPP4 inhibitors treatment in Syrian type 2 diabetic and impaired fasting glucose patients
Scientific title
Association of serological levels for death receptors
(TNFR1, TRAIL -R2, FAS ) before and after treatment with DPP4 inhibitors in Syrian
Type 2 Diabetic and Impaired fasting glucose patients.
Secondary ID [1] 312512 0
nill known
Universal Trial Number (UTN)
U1111-1310-6267
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
the research problem is to study serum apoptotic biomarkers and inflammatory mediators in naive drug prediabetes to determine whether drug intervention (DPP4inhibitors ) can slow down or reverse apoptosis of pancreatic beta cell in order to limit conversion prediabetes to T2DM . 334632 0
the research problem is to study serum apoptotic biomarkers and inflammatory mediators in naive drug , newly diagnosed T2DM to determine whether drug intervention (DPP4inhibitors ) can slow down or reverse apoptosis of pancreatic beta cell in order to limit conversion T2DM to insulin dependent diabetes 334633 0
Condition category
Condition code
Metabolic and Endocrine 331037 331037 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• Prediabetic group: newly diagnosed, naïve impaired fasting glucose diagnosed based on ADA guidelines, and it is treated orally with sitagliptin ( either 50 mg once or twice daily on 100mg once daily )for 6 months. according to clinician decision depend on fasting blood glucose (FBG) and
Hb A1C (50 mg given for either fasting blood glucose (FBG )less than 110 mg/dl and also for low value of Hb A1C less than 6% and adherence is controlled by giving drug each month .
• Type 2 diabetic group: Naïve, newly diagnosed based on ADA guidelines , and it is treated with combination of metformin and sitagliptin( doses and strength used fixed strength 50mg of sitagliptin combined either with 500mg , 850 mg , 1000mg of metformin ) taken orally twice daily . the course therapy based on the values of Hb A1C and the values of fasting blood glucose . (metformin 500, sitagliptin 50mg bid given either " FBG <200 mg/dl or HbA1C < 10% ", metformin 850,sitagliptin 50 bid given either " FBG ( ranges 200-240mg/dl , or HbA1C >10% " metformin 1000,sitagliptin 50 bid given either " FBG >240mg/dl or HbA1C >12%"
Of note exclusion individuals with CAD, and CKD, as well as chronic diseases and not previously treated with either hypoglycemic agents or metformin alone in IFG group.
DPP4 inhibitors will be administrated in combination with metformin for T2DM and DPP4 inhibitors will be given for prediabetes.
Intervention code [1] 329040 0
Treatment: Drugs
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338797 0
Plasma levels of TNFR1 will be assessed in both study groups before treatment with combination DPP4 inhibitors ( sitagliptin 50mg) and metformin(1000mg, 500mg, 850mg) for naïve newly diagnosed T2DM and administration sitagliptin (50mg or 100mg ) for naïve prediabetes.
Timepoint [1] 338797 0
Timepoint: Baseline, 24 weeks
after intervention commencement .
Primary outcome [2] 338991 0
plasma levels of Plasma levels of FAS will be assessed in both study groups before treatment with combination DPP4 inhibitors ( sitagliptin 50mg) and metformin(1000mg, 500mg, 850mg) for naïve newly diagnosed T2DM and administration sitagliptin (50mg or 100mg ) for naïve prediabetes.
Timepoint [2] 338991 0
measured at baseline and after 24 month from administration therapy ( sitagliptin for diabetes group ) and combination ( metformin /sitagliptin ) for type 2 diabetes group .
Primary outcome [3] 338992 0
plasma levels of Plasma levels of TRAIL-R2 will be assessed in both study groups before treatment with combination DPP4 inhibitors ( sitagliptin 50mg) and metformin(1000mg, 500mg, 850mg) for naïve newly diagnosed T2DM and administration sitagliptin (50mg or 100mg ) for naïve prediabetes.
Timepoint [3] 338992 0
measured at baseline and after 24 month from administration therapy ( sitagliptin for diabetes group ) and combination ( metformin /sitagliptin ) for type 2 diabetes group .
Secondary outcome [1] 437510 0

Fasting blood glucose levels will be analyzed by AMS kit (Italy) immediately after ( 8 hours overnight fast )blood withdrawing into heparin tube and collecting plasma after centrifugation for 5 minutes at 1500 rpm .measurement of fasting blood glucose by automatic analyzer ( AMS , ITALY). for both study groups .
Timepoint [1] 437510 0
at admission and after 24 weeks of intervention
Secondary outcome [2] 438871 0
HbA1c WILL BE ANALYZED after 8 hours overnight fast blood withdrawing into EDTA tube at admission and after 6 months treatment for both study groups
Timepoint [2] 438871 0
at admission and after 24 weeks of intervention
Secondary outcome [3] 438874 0
Plasma levels of triglycerides (TG) will ba analyzed for both study groups.
Timepoint [3] 438874 0
at admission and after 24 weeks of intervention
Secondary outcome [4] 439273 0
Plasma levels of total cholestrol (TOTAL chol) will be analyzed for both study groups .
Timepoint [4] 439273 0
at admission and after 24 weeks of intervention
Secondary outcome [5] 439274 0
plasma levels of low density lipoprotein LDL will analyzed for both study groups.
Timepoint [5] 439274 0
at admission and after 24 weeks of intervention
Secondary outcome [6] 439277 0
plasma levels of high density lipoprotein HDL will be analyzed for both study groups
Timepoint [6] 439277 0
at admission and after 24 weeks of intervention
Secondary outcome [7] 439278 0
plasma levels of ALT (aminotransferase enzyme ) will be analyzed for both study groups
Timepoint [7] 439278 0
at admission and after 24 weeks of intervention
Secondary outcome [8] 439279 0
plasma levels of AST ( aminotransferase enzyme) will be analyzed for both study groups.
Timepoint [8] 439279 0
at admission and after 24 weeks of intervention
Secondary outcome [9] 439280 0
plasma levels of urea will be analyzed for both study groups
Timepoint [9] 439280 0
at admission and after 24 weeks of intervention
Secondary outcome [10] 439281 0
plasma levels of creatinine for both study groups
Timepoint [10] 439281 0
at admission and after 24 weeks of intervention
Secondary outcome [11] 439282 0
CRP levels are assayed by turbidimetry method byBiorex diagnostics KIT(UK ) immediately after ( 8 hours overnight fast )blood withdrawing into heparin tube and collecting plasma after centrifugation for 5 minutes at 1500 rpm. .(time frame : at admission and after 6months treatment)
Timepoint [11] 439282 0
at admission and after 24 weeks of intervention
Secondary outcome [12] 439283 0
plasma levels of Plasma levels of FAS -LIGAND will be assessed in both study groups before treatment with combination DPP4 inhibitors ( sitagliptin 50mg) and metformin(1000mg, 500mg, 850mg) for naïve newly diagnosed T2DM and administration sitagliptin (50mg or 100mg ) for naïve prediabetes
Timepoint [12] 439283 0
at admission and after 24 weeks of intervention
Secondary outcome [13] 439284 0
plasma levels of Plasma levels of IL-1BETA will be assessed in both study groups before treatment with combination DPP4 inhibitors ( sitagliptin 50mg) and metformin(1000mg, 500mg, 850mg) for naïve newly diagnosed T2DM and administration sitagliptin (50mg or 100mg ) for naïve prediabetes
Timepoint [13] 439284 0
at admission and after 24 weeks of intervention

Eligibility
Key inclusion criteria
Naïve , Newly diagnosed prediabetes and type 2 diabetes.
Minimum age
36 Years
Maximum age
71 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of cardiovascular disease ,renal disease, tumor or autoimmune disease. Type 1 diabetes , type 2 diabetes treated by oral .hypoglycemic agents and prediabetes treated with metformin.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/06/2021
Date of last participant enrolment
Anticipated
Actual
30/11/2022
Date of last data collection
Anticipated
Actual
30/12/2022
Sample size
Target
88
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 26423 0
Syrian Arab Republic
State/province [1] 26423 0
damascus

Funding & Sponsors
Funding source category [1] 317303 0
Commercial sector/Industry
Name [1] 317303 0
IBN HAYTHAM PHARMACEUTICAL COMPANY FOR TREATMENT (SITAGLIPTIN AND THE COMBINATION )
Country [1] 317303 0
Syrian Arab Republic
Primary sponsor type
Individual
Name
rama ayash -Damascus university ,-pharmacy college
Address
Country
Syrian Arab Republic
Secondary sponsor category [1] 319583 0
None
Name [1] 319583 0
Address [1] 319583 0
Country [1] 319583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315689 0
Medical Ethics Committee of Damascus university
Ethics committee address [1] 315689 0
Ethics committee country [1] 315689 0
Syrian Arab Republic
Date submitted for ethics approval [1] 315689 0
12/05/2021
Approval date [1] 315689 0
12/05/2021
Ethics approval number [1] 315689 0
No. m/471 -12/5/2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135510 0
Dr rama ayash
Address 135510 0
syria damascus - FACULTY OF PHARMACY , MEZZEH HIGHWAY, STREET NAME : FAYEZ MANSOUR
Country 135510 0
Syrian Arab Republic
Phone 135510 0
+933761461
Fax 135510 0
Email 135510 0
[email protected]
Contact person for public queries
Name 135511 0
rama ayash
Address 135511 0
syria damascus - DAMASCUS UNIVERSITY ,FACULTY OF PHARMACY , MEZZEH HIGHWAY, STREET IS FAYEZ MANSOUR
Country 135511 0
Syrian Arab Republic
Phone 135511 0
+933761461
Fax 135511 0
Email 135511 0
[email protected]
Contact person for scientific queries
Name 135512 0
rama ayash
Address 135512 0
syria damascus - FACULTY OF PHARMACY ,MEZZEH HIGHWAY, FAYEZ MANSOR STREET
Country 135512 0
Syrian Arab Republic
Phone 135512 0
+933761461
Fax 135512 0
Email 135512 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
data available for 5 years after publication
Available to whom?
only for researchers
Available for what types of analyses?
only to achieve the
aims in the approved proposal,
How or where can data be obtained?
access subject to approvals
by Principal Investigator via
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.