Platelet Activity in T2DM Using Flowcytometry

NCT ID: NCT04027907

Last Updated: 2019-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-01

Study Completion Date

2021-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

-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 .

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Platelet Activity in T2DM Using Flowcytometry

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

T2DM

Flowcytometry

Intervention Type OTHER

detect platelet activity in T2DM by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63).

healthy controls

Flowcytometry

Intervention Type OTHER

detect platelet activity in T2DM by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Flowcytometry

detect platelet activity in T2DM by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hanaa M Ahmed

HMAmed

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

hanaa ahmed, master

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Fatema Abd-EL Moez, MD

Role: CONTACT

00201006564000

Mai mohamed, MD

Role: CONTACT

00201223971678

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 707914 (View on PubMed)

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.

Reference Type RESULT
PMID: 909154 (View on PubMed)

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.

Reference Type RESULT
PMID: 9680 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Plt activity by flowcytometry

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Patients With Type 2 Diabetes
NCT07245082 RECRUITING