NCT04027907

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 .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2019

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 18, 2019

Last Update Submit

July 18, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Platelet activity in type 2 diabetic patients using flowcytometry in relation to macrovascular complication.

    Baseline

Study Arms (2)

T2DM

Other: Flowcytometry

healthy controls

Other: Flowcytometry

Interventions

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

T2DMhealthy controls

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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 Officials

  • hanaa ahmed, master

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatema Abd-EL Moez, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
HMAmed

Study Record Dates

First Submitted

July 18, 2019

First Posted

July 22, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

July 22, 2019

Record last verified: 2019-07