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NCT05864079 Clinical Trial

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

Overweight and Obesity Clinical Trial

Official title:
Serum Levels of Developmental Endothelial Locus-1 and Its Relationship With Platelet Count and Soluble P-selectin in Overweight and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05864079
Other study ID # DEL-1 and sP-sel in obesity
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date April 1, 2024

Study information
Verified date June 2024
Source Aswan University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 ?

Recruitment information / eligibility
Status Completed
Enrollment 66
Est. completion date April 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Platelet count
Platelet count in study groups
• Developmental endothelial locus-1 (DEL-1)
Serum DEL-1 in study groups
• soluble P-selectin (sP-sel)
Serum sP-sel in study groups

Locations
Country Name City State
Egypt Aswan University Hospital Aswan

Sponsors (1)
Lead Sponsor Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Barale C, Russo I. Influence of Cardiometabolic Risk Factors on Platelet Function. Int J Mol Sci. 2020 Jan 17;21(2):623. doi: 10.3390/ijms21020623. — View Citation

Hajishengallis G, Chavakis T. DEL-1-Regulated Immune Plasticity and Inflammatory Disorders. Trends Mol Med. 2019 May;25(5):444-459. doi: 10.1016/j.molmed.2019.02.010. Epub 2019 Mar 15. — View Citation

Kwon CH, Sun JL, Kim MJ, Abd El-Aty AM, Jeong JH, Jung TW. Clinically confirmed DEL-1 as a myokine attenuates lipid-induced inflammation and insulin resistance in 3T3-L1 adipocytes via AMPK/HO-1- pathway. Adipocyte. 2020 Dec;9(1):576-586. doi: 10.1080/21623945.2020.1823140. — View Citation

Purdy JC, Shatzel JJ. The hematologic consequences of obesity. Eur J Haematol. 2021 Mar;106(3):306-319. doi: 10.1111/ejh.13560. Epub 2020 Dec 13. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Platelet count platelet count in venous blood samples in normal-weight, overweight, and obese subjects 6 months
Primary Serum Developmental endothelial locus-1 levels Serum developmental endothelial locus-1 in normal-weight, overweight, and obese subjects 6 months
Primary Serum Soluble P-selectin levels Serum Soluble P-selectin in normal-weight, overweight, and obese subjects 6 months
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