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

NCT05864079 | Completed

• 1 other identifier: DEL-1 and sP-sel in obesity
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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 ?

Conditions

Overweight and Obesity

Outcome Measures

Primary Outcomes (3)

• Platelet count

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

  6 months

• Serum Developmental endothelial locus-1 levels

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

  6 months

• Serum Soluble P-selectin levels

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

  6 months

Study Arms (3)

Control

22 healthy age-matched normal-weight male subjects (BMI is from 18.5 to \< 25)

Diagnostic Test: Platelet count; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Diagnostic Test: soluble P-selectin (sP-sel)

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; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Diagnostic Test: soluble P-selectin (sP-sel)

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; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Diagnostic Test: soluble P-selectin (sP-sel)

Interventions

Platelet count DIAGNOSTIC_TEST

Platelet count in study groups

Control; Obesity; Overweight

Developmental endothelial locus-1 (DEL-1) DIAGNOSTIC_TEST

Serum DEL-1 in study groups

Control; Obesity; Overweight

soluble P-selectin (sP-sel) DIAGNOSTIC_TEST

Serum sP-sel in study groups

Control; Obesity; Overweight

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy overweight and obese subjects

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

Related Publications (4)

• 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.

  PMID: 30885428 BACKGROUND

• 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.

  PMID: 33270290 BACKGROUND

• 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.

  PMID: 31963572 BACKGROUND

• 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.

  PMID: 32954935 BACKGROUND

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Platelet Count

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Platelet Function Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Asmaa Abdelmageed Muhammed, lecturer

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 18, 2023
• Study Start: June 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: April 1, 2024
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

EG (1)