Platelet Activity in T2DM Using Flowcytometry

Platelet Activity in Type 2 Diabetic Patients Using Flowcytometry in Relation to Macrovascular Complication.

-Describe platelet activity in type 2 diabetes as a participant in vascular inflammation. -Compare platelet activity in patients with type 2 diabetes mellitus versus healthy controls. -Study and describe platelet activity in patients with type 2 diabetes mellitus in association with ischemic cardiovascular disease in relation to duration of diabetes mellitus .

Study Overview

• Status: Unknown
• Conditions: Platelet Activity in T2DM Using Flowcytometry
• Intervention / Treatment: Other: Flowcytometry

Detailed Description

Type2diabetes mellitus(T2DM)is most prevalent and costly chronic disease(Leon et al 2015).according to IDF a further increase to 642million diagnosed individual by2040(Ogurtsova et al 2017).the major cause of morbidity and mortality in DM is macrovascular complications.75% of diabetic patients die of cardiovascular disease(CVD)( Ridker et al2017).Platelets are one of blood cells 1,5-3um in size and survive 8-10days ,their function extended beyond homestasis and thrombosis to be an active participant in intiating and sustaining vascular inflammation as well as in prothrombotic complications of CVD(Festa et al2002).platelets are hyperactive in diabetic patients ,the coagulation cascade is dysfunctional ,platelet inT2DM adhere to vascular endothelium and aggregate more readily than those in healthy people(Pretorius2011)*.platelets are activated when they are in contact with damaged vascular endothelium , once activated they secrete awide spectrum of inflammatory mediators , once they are activated , they intiate reactions by changes in the level of expression of surface glycoproteins(GP)results , which act as receptors for platelet agonist and for adhesive proteins involved in platelet aggregation(Pretorius etal2015)**.platelet activity can be measured by flow cytometry ,as flow cytometry allows the simultaneous detection of surface antigens in a sensitive and specific manner , it is therefore possible to examine aspects of the platelet membrane activity . the available platelet markers areCD41a marker forGP2b ,CD42 a marker for GP1b.both are used for platelet identification.( Pretorius et al 2017)***.CD62 a marker for P-selectin ,anti-CD62 react with alpha granule membrane protein which is expressed on the surface of activated platelet.CD63 a marker for GP4 and anti-CD63 react with lysosomal granule-membrane glycoprotein that is expressed on surface of activated platelet. CD62andCD63 are markers of platelet activation (Ibrahim et al 2017).knowing the major role of platelets in inflammatory and healing process in the vascular system especially in diabetic patients ,created the urgency to study the impact of platelet activity in diabetic patients whom has macrovascular risk using flowcytometry.

• Study Type: Observational
• Enrollment (Anticipated): 122

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients will be recruited from Internal medicine department and Diabetes out patient clinic in Assuit University Hospital.

Controls will be health workers and paramedicals in Assuit university hospital.

Description

Inclusion Criteria:

• The study will include patient with type II diabetes at age of 30-60 years old with or without ischemic cardiovascular disease. . Controls will be healthy individuals with normal blood glucose level of same matched age group.

Exclusion Criteria: 1)Type1Diabetes mellitus. 2)Hypertensive patients. 3)patients with renal impairment. 4) patients with hepatic impairment. 5)patients with thrombocytopenia. 6)Pregnancy.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy controls	Other: Flowcytometry; detect platelet activity in T2DM by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63).
T2DM	Other: Flowcytometry; detect platelet activity in T2DM by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet activity in type 2 diabetic patients using flowcytometry in relation to macrovascular complication.	Dedect platelet activity by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63)	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet activity in type 2 diabetic patients using flowcytometry in relation to macrovascular complication.	Dedect platelet number by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD41 and CD42)	Baseline

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: hanaa ahmed, master, Assiut University

Publications and helpful links

General Publications

• Castaigne F, Liber E, Carbillet L, Boulet M, Riel RR. [New procedure for protein spinning: the hydrodynamic process]. Ann Nutr Aliment. 1978;32(2-3):217-31. French.
• Gulati RB, Wadia RS, Shaikh RA, Soares PM, Grant KB. Precordial mapping in acute myocardial infarction. Jpn Heart J. 1977 Jul;18(4):447-56. doi: 10.1536/ihj.18.447.
• Gheorghiu T, Badescu A. [Dynamcis of immunocompetent cells in the contralateral lymph node in grafted cancer, under the influence of some factors stimulating and inhibiting the CNS in rats]. Rev Med Chir Soc Med Nat Iasi. 1976 Jan-Mar;80(1):79-84. No abstract available. Romanian.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 18, 2019
• First Posted (ACTUAL): July 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Plt activity by flowcytometry

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No