Developmental Endothelial Locus-1, Platelet Count, and Soluble P-selectin in Overweight and Obese Subjects

Completed

• Conditions: Overweight and Obesity
• Interventions: Diagnostic Test: Platelet count; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Diagnostic Test: soluble P-selectin (sP-sel)

• Registration Number: NCT05864079
• Lead Sponsor: Aswan University Hospital

Brief Summary

This observational study aims to detect serum levels of Developmental Endothelial Locus-1 (DEL-1), Platelet Count, and Soluble P-selectin (sP-sel) in Overweight and Obese Subjects. The main questions it aims to answer are:

* Is there a difference in serum DEl-1 levels in overweight and obese subjects compared to normal subjects?

* Are there any relations between serum DEL-1 levels, sP-sel, and platelet count in overweight and obese subjects ?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-09
• Study First Submitted QC: 2023-05-09
• Study First Posted: 2023-05-18
• Study Start: 2023-06-01
• Primary Completion: 2024-02-01
• Study Completion: 2024-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-06
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 66

Inclusion Criteria

• Male patients.
• Age (18-65) years.
• Healthy overweight and subjects.

Exclusion Criteria

• Patients with cardiovascular diseases.
• Diabetic patients.
• Previous history of thrombo-embolic diseases.
• Patients with hyperthyroidism.
• Patients with any type of malignancy.
• Underlying hepatic or renal failure.
• Major surgery within 60 days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	soluble P-selectin (sP-sel)	22 healthy age-matched normal-weight male subjects (BMI is from 18.5 to \< 25)
Control	Platelet count	22 healthy age-matched normal-weight male subjects (BMI is from 18.5 to \< 25)
Obesity	Platelet count	22 healthy obese male subjects (BMI is ≥ 30). Patients with cardiovascular diseases, any malignancy, hepatic or renal failure, diabetic, hyperthyroid patients, patients with a previous history of thromboembolic diseases, or with a history of major surgery within 60 days will be excluded.
Overweight	soluble P-selectin (sP-sel)	22 healthy overweight male subjects (BMI is from 25 to \< 30). Patients with cardiovascular diseases, any malignancy, hepatic or renal failure, diabetic, hyperthyroid patients, patients with a previous history of thromboembolic diseases, or with a history of major surgery within 60 days will be excluded.
Obesity	Developmental endothelial locus-1 (DEL-1)	22 healthy obese male subjects (BMI is ≥ 30). Patients with cardiovascular diseases, any malignancy, hepatic or renal failure, diabetic, hyperthyroid patients, patients with a previous history of thromboembolic diseases, or with a history of major surgery within 60 days will be excluded.
Control	Developmental endothelial locus-1 (DEL-1)	22 healthy age-matched normal-weight male subjects (BMI is from 18.5 to \< 25)
Overweight	Platelet count	22 healthy overweight male subjects (BMI is from 25 to \< 30). Patients with cardiovascular diseases, any malignancy, hepatic or renal failure, diabetic, hyperthyroid patients, patients with a previous history of thromboembolic diseases, or with a history of major surgery within 60 days will be excluded.
Overweight	Developmental endothelial locus-1 (DEL-1)	22 healthy overweight male subjects (BMI is from 25 to \< 30). Patients with cardiovascular diseases, any malignancy, hepatic or renal failure, diabetic, hyperthyroid patients, patients with a previous history of thromboembolic diseases, or with a history of major surgery within 60 days will be excluded.
Obesity	soluble P-selectin (sP-sel)	22 healthy obese male subjects (BMI is ≥ 30). Patients with cardiovascular diseases, any malignancy, hepatic or renal failure, diabetic, hyperthyroid patients, patients with a previous history of thromboembolic diseases, or with a history of major surgery within 60 days will be excluded.

Primary Outcome Measures

Name	Time	Method
Serum Developmental endothelial locus-1 levels	6 months	Serum developmental endothelial locus-1 in normal-weight, overweight, and obese subjects
Serum Soluble P-selectin levels	6 months	Serum Soluble P-selectin in normal-weight, overweight, and obese subjects
Platelet count	6 months	platelet count in venous blood samples in normal-weight, overweight, and obese subjects

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt