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

May 17, 2023 updated by: Asmaa Abdel-mageed Muhammed, Aswan University Hospital

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

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 ?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Aswan, Egypt, 81528
        • Aswan University Hospital
        • Contact:
        • Principal Investigator:
          • Mohammed Mohiey El-Din Fouad, Lecturer
        • Principal Investigator:
          • Amani Muhammed Abdelfattah Seleem, Demonstrator
        • Principal Investigator:
          • Rania Mohammed Hassan, A. professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Healthy overweight and obese subjects

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aswan University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

May 9, 2023

First Posted (Actual)

May 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEL-1 and sP-sel in obesity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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