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NCT Number: NCT06897904

Basic Hematological Parameters and Coagulation Profile in Type 1 Diabetic Children

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 .

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Assiut university hospitals

Asyut, Asyut Governorate, 2067011, Egypt

Location status: Recruiting

Location contact

Ramez Nady

CONTACT

[email protected]

08822080150

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

Primary outcomes

  1. Prothrombin time

    Time frame: baseline

    comparison of prothrombin time between T1DM children and healthy controls

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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