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Clinical Trials/NCT06897904
NCT06897904RecruitingNot Applicable

Basic Hematological Parameters and Coagulation Profile in Type 1 Diabetic Children

Assiut University1 site in 1 country110 target enrollmentStarted: April 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
110
Locations
1
Primary Endpoint
Prothrombin time

Study Overview

Brief Summary

Diabetes mellitus is a group of chronic metabolic diseases characterized by hyperglycemia .Type 1 diabetes is a heterogeneous disease related to the destruction of pancreatic beta cells and is a result of absolute lack of insulin

  • Diabetes mellitus has been traditionally looked upon as a disease of adults (except Type I diabetes), however it can affect individuals of any age. Given the peculiarities and problems that it carries, diabetes in children and adolescents poses special challenges to the entire society. Diabetes is the second commonest chronic disease occurring in 1 in every 1500 children by age 5 and in 1 in 350 children by age 8 . Microvascular (retinopathy, neuropathy, and nephropathy) Aim of the research to assess basic hematological parameters and coagulation profiles among type 1 diabetic children and compare them with healthy controls and macrovascular (coronary artery disease, peripheral vascular disease, and cerebrovascular disease) atherothrombotic complications may occur in children and adolescents, depending on the duration of diabetes, the degree of metabolic control, and other factorssuch as genetics . Diabetes mellitus can cause blood disorders such as deformity of red blood cells and increase their adhesion [6].It has an effect on the function of red blood cells through the interaction with the membrane and intracellular components . Red blood cell distribution width (RDW) is a measure of the difference in the size of red blood cells. An increase in RDW can be caused by anemia or nutritional deficiencies related to anemia
  • Studies have shown that the average number of red blood cells, hemoglobin and hematocrit in diabetic patients is lower than the control group, which indicates the presence of anemia in diabetic patients .

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
— to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age from one month to 18 year.
  • •Both sexes.
  • •Patients known to have type 1 diabetes.

Exclusion Criteria

  • •Patients less than one month and more than 18years.
  • •history of bleeding disorders or anemia unrelated to diabetes.
  • •Otherc types of diabetes .

Arms & Interventions

diabetic group

type 1 diabetic children

control group

healthy control

Outcomes

Primary Outcomes

Prothrombin time

Time Frame: baseline

comparison of prothrombin time between T1DM children and healthy controls

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ramez Nady Kamel Ragheb

Residant doctor

Assiut University

Study Sites (1)

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