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出境医 / 临床实验 / Platelet Activity in T2DM Using Flowcytometry
Platelet Activity in T2DM Using Flowcytometry
Study Description
Brief Summary:
-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 .
| Condition or disease | Intervention/treatment |
|---|---|
| Platelet Activity in T2DM Using Flowcytometry | 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 Design
| Study Type : | Observational |
| Estimated Enrollment : | 122 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Platelet Activity in Type 2 Diabetic Patients Using Flowcytometry in Relation to Macrovascular Complication. |
| Estimated Study Start Date : | October 1, 2019 |
| Estimated Primary Completion Date : | October 1, 2021 |
| Estimated Study Completion Date : | December 1, 2021 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
| T2DM |
Other: Flowcytometry
detect platelet activity in T2DM by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63).
|
| 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).
|
Outcome Measures
Primary Outcome Measures :
- Platelet activity in type 2 diabetic patients using flowcytometry in relation to macrovascular complication. [ Time Frame: Baseline ]Dedect platelet activity by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63)
Secondary Outcome Measures :
- Platelet activity in type 2 diabetic patients using flowcytometry in relation to macrovascular complication. [ Time Frame: Baseline ]Dedect platelet number by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD41 and CD42)
Eligibility Criteria
| Ages Eligible for Study: | 30 Years to 60 Years (Adult) |
| Sexes 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.
Criteria
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.
Contacts and Locations
Contacts
| Contact: Fatema Abd-EL Moez, MD | 00201006564000 | Fatmaelosily@yahoo.com | |
| Contact: Mai mohamed, MD | 00201223971678 | maialy24983@gmail.com |
Sponsors and Collaborators
Assiut University
Investigators
| Principal Investigator: | hanaa ahmed, master | Assiut University |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | July 18, 2019 | ||||||||
| First Posted Date | July 22, 2019 | ||||||||
| Last Update Posted Date | July 22, 2019 | ||||||||
| Estimated Study Start Date | October 1, 2019 | ||||||||
| Estimated Primary Completion Date | October 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Platelet activity in type 2 diabetic patients using flowcytometry in relation to macrovascular complication. [ Time Frame: Baseline ] Dedect platelet activity by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63)
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
Platelet activity in type 2 diabetic patients using flowcytometry in relation to macrovascular complication. [ Time Frame: Baseline ] Dedect platelet number by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD41 and CD42)
|
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| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Platelet Activity in T2DM Using Flowcytometry | ||||||||
| Official Title | Platelet Activity in Type 2 Diabetic Patients Using Flowcytometry in Relation to Macrovascular Complication. | ||||||||
| Brief Summary | -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 | 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 | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
||||||||
| Condition | Platelet Activity in T2DM Using Flowcytometry | ||||||||
| Intervention | Other: Flowcytometry
detect platelet activity in T2DM by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63).
|
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Not yet recruiting | ||||||||
| Estimated Enrollment |
122 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | December 1, 2021 | ||||||||
| Estimated Primary Completion Date | October 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria: 1)Type1Diabetes mellitus. 2)Hypertensive patients. 3)patients with renal impairment. 4) patients with hepatic impairment. 5)patients with thrombocytopenia. 6)Pregnancy. |
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| Sex/Gender |
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| Ages | 30 Years to 60 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04027907 | ||||||||
| Other Study ID Numbers | Plt activity by flowcytometry | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Hanaa M Ahmed, Assiut University | ||||||||
| Study Sponsor | Assiut University | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Assiut University | ||||||||
| Verification Date | July 2019 | ||||||||
