CompletedPhase 4ACTRN12624001135505

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

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.

Sponsor

rama ayash -Damascus university ,-pharmacy college

Enrollment

88 participants

Start Date

Jun 21, 2021

Study Type

Interventional

Conditions

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 .

Summary

As ß Cell Vanish Prior T2DM Incidence , and apoptosis is the underlying cause for ß-Cell loss, as well as it is histological event which represents snapshot in time , as well as it is difficult to determine in tissue samples as it is invasive and inconvenient. Furthermore, several studies have exerted that DPP4 inhibitors suppressed some apoptotic biomarkers in tissue thereby preserved beta cell mass . In the present study we investigate whether DPP4i would effectively alleviate beta cell apoptosis by decreasing serum levels of death receptors in T2DM and prediabetic patients . .

Eligibility

Sex: Both males and femalesMin Age: 36 YearssMax Age: 71 Yearss

Inclusion Criteria1

Naïve , Newly diagnosed prediabetes and type 2 diabetes.

Exclusion Criteria1

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.

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Interventions

• 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.

Locations(1)

damascus, Syrian Arab Republic

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ACTRN12624001135505