Vascular Complication, DiabeticNCT06073756
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
An observational study of Vascular Complication, Diabetic, run by Assiut University.
Trial summary
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Vascular Complication, Diabetic
- What is being tested?
- Echocardiogram
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Dec 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Adult, Older adult
Study population: Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
Read the 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
- Conditions
- Vascular Complication, Diabetic
- Being tested
- Echocardiogram
- Keywords
- Neutrophils to lymhocyte ratio and platelets to lymhocyte ratio
- Medical subject headings
- Diabetic Angiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiogramRadiation
Also called ALB / cr ratio, Fundus examination, ECG, Doppler on lower limbs
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
| Study group | Role | What they receive |
|---|---|---|
| 1 | Type 2 diabetes mellitus (T2DM) patients with good glycemic control and have HBA1C <7and ages ranging from ≥18 old. Receives: Radiation: Echocardiogram | |
| 2 | Type 2 diabetes mellitus (T2DM) patients with poor glycemic control and have HBA1C ≥7 and ages rang from ≥ 18 years old Receives: Radiation: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-to-lymphocyte ratio and platelets to lymphocytes ratio
Measurement of Neutrophils to lymhocyte ratio and platelets to lymhocyte ratio in patients with type 2 DM
Measured: Basline
Secondary outcomes (1)
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
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
Measured: Basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study startDec 2023 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Complication, DiabeticStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ammar Ashraf fathy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073756
- Sponsor's protocol ID
- NLR and PLR and in type 2 DM
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06073756
- Acronym / sponsor ID
- NLR and PLR and in type 2 DM
- Conditions
- Vascular Complication, Diabetic
- Keywords
- Neutrophils to lymhocyte ratio and platelets to lymhocyte ratio
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 10 Oct 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.
Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Radiation: EchocardiogramType 2 diabetes mellitus (T2DM) patients with good glycemic control and have HBA1C <7and ages ranging from ≥18 old. |
| 2 | – | Radiation: EchocardiogramType 2 diabetes mellitus (T2DM) patients with poor glycemic control and have HBA1C ≥7 and ages rang from ≥ 18 years old |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Evaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Patients with, type 1 diabetes mellitus
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 |
|---|---|---|
| EchocardiogramAlso: ALB / cr ratio, Fundus examination, ECG, Doppler on lower limbsEvaluate PLR and NLR and their assiotation to vascular complications and glycemic control in type 2 DM | Radiation | 1, 2 |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
Related trials for Vascular Complication, Diabetic
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Vascular Complication, Diabetic, run by Assiut University.
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 1 inclusion and 5 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: opening soon, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ammar Ashraf Fathy (01028177808, ammarashraf154@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-to-lymphocyte ratio and platelets to lymphocytes ratio (time frame: Basline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2023.