- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06073756
Neutrophil-lymphocyte and Platelet-lymphocyte Ratios and Their Relations to Vascular Comlications and Glycemic Control in Patients With Type 2 Diabetes Attending The Diabetes Center of Assiut University Hospitals
October 3, 2023 updated by: Ammar Ashraf fathy, Assiut University
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Vascular complications of DM result from various disorders including metabolic, cellular, and blood disturbances.
Excessive production of pro-inflammatory adipokines from adipose tissue, resulting in low-grade chronic inflammation, causing insulin resistance (IR) and type 2 DM [3].
Hematological changes affecting the red blood cells (RBCs), white blood cells (WBCs), platelet function, and the coagulation factors are detected to be associated with DM .
It is important to add that, high WBC count, one of the chief components of inflammatory process, sharing to atheroscle-rosis development and cardiovascular diseases (CVD) .
Lately, the neutrophil-to-lymphocyte (N/L) and the platelet-to-lymphocyte (P/L) ratios, were offered as markers of inflammation in cardiac diseases, neoplasms and diabetes-related complications .
Moreover, high leucocyte counts have been used as diagnostic and prognostic markers in vascular complication of diabetes
Study Type
Observational
Enrollment (Estimated)
106
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
- Name: Ammar Ashraf Fathy
- Phone Number: 01028177808
- Email: ammarashraf154@gmail.com
Study Contact Backup
- Name: Salah abdelazem Argoon
- Phone Number: 01019683366
- Email: argoons@yahoo.com
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
N/A
Sampling Method
Non-Probability Sample
Study Population
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
Description
Inclusion Criteria:
- Type 2 diabetes mellitus (T2DM) patients with good glycemic control and have HBA1C <7and ages ranging from ≥18 old. And poor glycemic control and have HBA1C ≥7 and ages rang from ≥ 18 years old
Exclusion Criteria:
Patients with, type 1 diabetes mellitus
- Idiopathic thrombocytopenic purpura,
- liver cell failure
- Myeloproliferative neoplasm
- patients on anticoagulant drugs , anti platelet drugs or on steroids were excluded from the study
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 |
|---|---|
|
1
Type 2 diabetes mellitus (T2DM) patients with good glycemic control and have HBA1C <7and ages ranging from ≥18 old.
|
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
Other Names:
|
|
2
Type 2 diabetes mellitus (T2DM) patients with poor glycemic control and have HBA1C ≥7 and ages rang from ≥ 18 years old
|
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neutrophil-to-lymphocyte ratio and platelets to lymphocytes ratio
Time Frame: Basline
|
Measurement of Neutrophils to lymhocyte ratio and platelets to lymhocyte ratio in patients with type 2 DM
|
Basline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HbA1c with good glycemic control and have HBA1C lower than 7and poor glycemic control and have HBA1C higher than 7with prescence or abscence of vascular complications
Time Frame: Basline
|
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
|
Basline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
Helpful Links
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 (Estimated)
December 1, 2023
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
October 3, 2023
First Submitted That Met QC Criteria
October 3, 2023
First Posted (Estimated)
October 9, 2023
Study Record Updates
Last Update Posted (Estimated)
October 9, 2023
Last Update Submitted That Met QC Criteria
October 3, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NLR and PLR and in type 2 DM
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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