Overweight and ObesityNCT05864079
Developmental Endothelial Locus-1, Platelet Count, and Soluble P-selectin in Overweight and Obese Subjects
An observational study of Overweight and Obesity, run by Aswan University Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Platelet count, Developmental endothelial locus-1 (DEL-1) and soluble P-selectin (sP-sel)
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Healthy overweight and obese subjects
Who may be able to join
- Male patients.
- Age (18-65) years.
- Healthy overweight and subjects.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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 ?
- Conditions
- Overweight and Obesity
- Being tested
- Platelet count, Developmental endothelial locus-1 (DEL-1), soluble P-selectin (sP-sel)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet countDiagnostic test
Platelet count in study groups
Developmental endothelial locus-1 (DEL-1)Diagnostic test
Serum DEL-1 in study groups
soluble P-selectin (sP-sel)Diagnostic test
Serum sP-sel in study groups
| Study group | Role | What they receive |
|---|---|---|
| Control | 22 healthy age-matched normal-weight male subjects (BMI is from 18.5 to < 25) Receives: 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. Receives: 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. Receives: Diagnostic Test: Platelet count; Diagnostic Test: Developmental endothelial locus-1 (DEL-1); Diagnostic Test: soluble P-selectin (sP-sel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet count
platelet count in venous blood samples in normal-weight, overweight, and obese subjects
Measured: 6 months
Serum Developmental endothelial locus-1 levels
Serum developmental endothelial locus-1 in normal-weight, overweight, and obese subjects
Measured: 6 months
Serum Soluble P-selectin levels
Serum Soluble P-selectin in normal-weight, overweight, and obese subjects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jun 2023
- Primary completion1 Feb 2024
- Study completion1 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Abdel-mageed Muhammed, Aswan University Hospital
- Investigators
- Asmaa Abdelmageed Muhammed, lecturer, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05864079
- Sponsor's protocol ID
- DEL-1 and sP-sel in obesity
- Status last verified
- Jun 2024
- First submitted
- 9 May 2023
- Last updated
- 7 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30885428Purdy 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.
PubMed 33270290Barale 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.
PubMed 31963572Kwon 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.
PubMed 32954935
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Levels of Developmental Endothelial Locus-1 and Its Relationship With Platelet Count and Soluble P-selectin in Overweight and Obese Subjects
- ClinicalTrials.gov ID
- NCT05864079
- Acronym / sponsor ID
- DEL-1 and sP-sel in obesity
- Conditions
- Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 18 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Platelet count, Diagnostic Test: Developmental endothelial locus-1 (DEL-1), Diagnostic Test: soluble P-selectin (sP-sel)22 healthy age-matched normal-weight male subjects (BMI is from 18.5 to < 25) |
| Overweight | – | Diagnostic Test: Platelet count, Diagnostic Test: Developmental endothelial locus-1 (DEL-1), Diagnostic Test: 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 | – | Diagnostic Test: Platelet count, Diagnostic Test: Developmental endothelial locus-1 (DEL-1), Diagnostic Test: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy overweight and obese subjects
Key inclusion criteria (3 listed)
- Male patients.
- Age (18-65) years.
- Healthy overweight and subjects.
Key exclusion criteria (7 listed)
- Patients with cardiovascular diseases.
- Diabetic patients.
- Previous history of thrombo-embolic diseases.
- Patients with hyperthyroidism.
- Patients with any type of malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet countPlatelet count in study groups | Diagnostic test | Control, Obesity, Overweight |
| Developmental endothelial locus-1 (DEL-1)Serum DEL-1 in study groups | Diagnostic test | Control, Obesity, Overweight |
| soluble P-selectin (sP-sel)Serum sP-sel in study groups | Diagnostic test | Control, Obesity, Overweight |
Primary outcome
Platelet count
Time frame: 6 months
platelet count in venous blood samples in normal-weight, overweight, and obese subjects
Serum Developmental endothelial locus-1 levels
Time frame: 6 months
Serum developmental endothelial locus-1 in normal-weight, overweight, and obese subjects
Serum Soluble P-selectin levels
Time frame: 6 months
Serum Soluble P-selectin in normal-weight, overweight, and obese subjects
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Background: PubMed 30885428Hajishengallis 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.
- Background: PubMed 33270290Purdy 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.
- Background: PubMed 31963572Barale 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.
- Background: PubMed 32954935Kwon 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa Abdelmageed Muhammed, lecturer principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Aswan University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet count (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05864079, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.