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

• Sponsor: Aswan University Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05864079
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Anticipated Duration (Months): 13
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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 ?

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity	Diagnostic Test: Platelet count; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Diagnostic Test: soluble P-selectin (sP-sel)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 66 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Serum Levels of Developmental Endothelial Locus-1 and Its Relationship With Platelet Count and Soluble P-selectin in Overweight and Obese Subjects
• Anticipated Study Start Date: Jun 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Control 22 healthy age-matched normal-weight male subjects (BMI is from 18.5 to < 25)	Diagnostic Test: Platelet count; Platelet count in study groups; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Serum DEL-1 in study groups; Diagnostic Test: soluble P-selectin (sP-sel); Serum sP-sel in study groups
Overweight 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.	Diagnostic Test: Platelet count; Platelet count in study groups; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Serum DEL-1 in study groups; Diagnostic Test: soluble P-selectin (sP-sel); Serum sP-sel in study groups
Obesity 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.	Diagnostic Test: Platelet count; Platelet count in study groups; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Serum DEL-1 in study groups; Diagnostic Test: soluble P-selectin (sP-sel); Serum sP-sel in study groups

Outcome Measures

Primary Outcome Measures

1. Platelet count [6 months]

   platelet count in venous blood samples in normal-weight, overweight, and obese subjects

2. Serum Developmental endothelial locus-1 levels [6 months]

   Serum developmental endothelial locus-1 in normal-weight, overweight, and obese subjects

3. Serum Soluble P-selectin levels [6 months]

   Serum Soluble P-selectin in normal-weight, overweight, and obese subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aswan University Hospital	Aswan		Egypt	81528

Sponsors and Collaborators

• Aswan University Hospital

Investigators

• Principal Investigator: Asmaa Abdelmageed Muhammed, lecturer, Aswan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Asmaa Abdel-mageed Muhammed, Lecturer, Aswan University Hospital
• ClinicalTrials.gov Identifier: NCT05864079
• Other Study ID Numbers: DEL-1 and sP-sel in obesity
• First Posted: May 18, 2023
• Last Update Posted: May 19, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of May 19, 2023