Basic Hematological Parameters and Coagulation Profile in Type 1 Diabetic Children

NCT06897904 | Not Yet Recruiting DMC

• 1 other identifier: hemo& coag type 1 DM
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Prothrombin time

  comparison of prothrombin time between T1DM children and healthy controls

  baseline

Study Arms (2)

diabetic group

type 1 diabetic children

control group

healthy control

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

type 1 diabetic children and matched healthy controls.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Residant doctor

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 27, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 27, 2025

Record last verified: 2025-03