Platelet IndicesNCT07363122
Platelet Changes in Type 2 Diabetes
An observational study of Platelet Indices and Type 2 Diabetes, run by Assiut University.
Trial summary
This study examines changes in platelet indices in people with type 2 diabetes compared to healthy people. It checks if these changes relate to inflammation markers (like hs-CRP) and blood sugar control. Participants get routine blood tests during one clinic visit at Assiut University Hospitals. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Indices, Type 2 Diabetes, Inflammatory Markers
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Mar 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200 adults aged 30-70 years recruited from Assiut University Hospitals and clinics: 100 with type 2 diabetes mellitus (T2DM, diagnosed ≥1 year, fasting glucose ≥126 mg/dL or HbA1c ≥6.5%) and 100 healthy controls without diabetes or major illness. Both groups undergo single assessments of platelet indices (MPV, PDW, P-LCR, PCT via CBC), inflammatory markers (hs-CRP, ESR), and glycemic parameters (fasting/postprandial glucose, HbA1c).
Who may be able to join
- Adults aged 30-70 years.
- Diagnosed T2DM for at least 1 year.
- Fasting blood glucose ≥126 mg/dL and/or HbA1c ≥ 6.5%
Who cannot join
- Type 1 Diabetes Mellitus
- Acute infection, chronic inflammatory disease
- Malignancy.
- Current use of anti-platelet or anti-inflammatory medications
- Chronic liver, renal, or hematologic disease
- Recent major surgery or trauma (within 3 months)
About this study
Official title: Platelet Indices Changes in Type 2 Diabetes Mellitus and Their Relationship With Inflammatory Markers
This study examines changes in platelet indices in people with type 2 diabetes compared to healthy people. It checks if these changes relate to inflammation markers (like hs-CRP) and blood sugar control. Participants get routine blood tests during one clinic visit at Assiut University Hospitals. No treatments or extra procedures are involved.
Read the detailed description
Type 2 Diabetes Mellitus (T2DM) is characterized by chronic low-grade inflammation and hyperglycemia, which may alter platelet activation and morphology, potentially increasing cardiovascular risk. This cross-sectional case-control study aims to evaluate platelet indices, specifically mean platelet volume (MPV), platelet distribution width (PDW), platelet-large cell ratio (P-LCR), and plateletcrit (PCT), in T2DM patients compared to healthy controls. Additionally, it investigates the correlation between these indices and inflammatory biomarkers, including high-sensitivity C-reactive protein (hs-CRP) and erythrocyte sedimentation rate (ESR), as well as glycemic parameters such as fasting blood glucose, postprandial blood glucose, and glycosylated hemoglobin (HbA1c).
The study will be conducted at Assiut University Hospitals and clinics, enrolling 100 adult patients (aged 30-70 years) diagnosed with T2DM for at least one year and 100 healthy age-matched controls. Exclusion criteria include type 1 diabetes, acute infections, malignancies, chronic inflammatory or hematologic diseases, recent major surgery or trauma, and current use of anti-platelet or anti-inflammatory medications. All participants will undergo a complete medical history, clinical examination, and blood sampling for complete blood count (CBC) and biochemical analysis.
- Conditions
- Platelet Indices, Type 2 Diabetes, Inflammatory Markers
- Keywords
- Platelets, Platelet indices, T2DM, Type 2 Diabetes Mellitus, inflammatory markers
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T2DM Patients | 100 adults aged 30-70 years diagnosed with type 2 diabetes mellitus (T2DM) for ≥1 year (fasting glucose ≥126 mg/dL or HbA1c ≥6.5%), assessed for platelet indices (MPV, PDW, etc.), inflammatory markers (hs-CRP, ESR), and glycemic parameters via single blood draw and clinical evaluation; exclusions include type 1 DM, infections, anti-platelet drugs. | |
| Healthy Controls | 100 healthy adults aged 30-70 years without diabetes or major systemic illness, evaluated similarly for platelet indices, inflammatory markers, and basic glycemic parameters as comparators in this cross-sectional case-control study at Assiut University Hospitals. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Platelet Volume (MPV)
Difference in mean platelet volume (MPV) measured from complete blood count between T2DM patients and healthy controls. MPV reflects platelet activation and size, expected to be elevated in T2DM due to inflammation and hyperglycemia.
Measured: Single measurement at enrollment
Secondary outcomes (1)
High-sensitivity C-reactive Protein (hs-CRP)
Serum levels of high-sensitivity C-reactive protein (hs-CRP) in T2DM patients compared to healthy controls, as a marker of systemic inflammation potentially linked to platelet changes.
Measured: Single measurement at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet IndicesStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Hassan Mostafa Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363122
- Sponsor's protocol ID
- Platelet indices in T2DM
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Indices Changes in Type 2 Diabetes Mellitus and Their Relationship With Inflammatory Markers
- ClinicalTrials.gov ID
- NCT07363122
- Acronym / sponsor ID
- Platelet indices in T2DM
- Conditions
- Platelet Indices, Type 2 Diabetes, Inflammatory Markers
- Keywords
- Platelets, Platelet indices, T2DM, Type 2 Diabetes Mellitus, inflammatory markers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Jan 2026 (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 study examines changes in platelet indices in people with type 2 diabetes compared to healthy people. It checks if these changes relate to inflammation markers (like hs-CRP) and blood sugar control. Participants get routine blood tests during one clinic visit at Assiut University Hospitals. No treatments or extra procedures are involved.
Detailed description
Type 2 Diabetes Mellitus (T2DM) is characterized by chronic low-grade inflammation and hyperglycemia, which may alter platelet activation and morphology, potentially increasing cardiovascular risk. This cross-sectional case-control study aims to evaluate platelet indices, specifically mean platelet volume (MPV), platelet distribution width (PDW), platelet-large cell ratio (P-LCR), and plateletcrit (PCT), in T2DM patients compared to healthy controls. Additionally, it investigates the correlation between these indices and inflammatory biomarkers, including high-sensitivity C-reactive protein (hs-CRP) and erythrocyte sedimentation rate (ESR), as well as glycemic parameters such as fasting blood glucose, postprandial blood glucose, and glycosylated hemoglobin (HbA1c).
The study will be conducted at Assiut University Hospitals and clinics, enrolling 100 adult patients (aged 30-70 years) diagnosed with T2DM for at least one year and 100 healthy age-matched controls. Exclusion criteria include type 1 diabetes, acute infections, malignancies, chronic inflammatory or hematologic diseases, recent major surgery or trauma, and current use of anti-platelet or anti-inflammatory medications. All participants will undergo a complete medical history, clinical examination, and blood sampling for complete blood count (CBC) and biochemical analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM Patients | – | –100 adults aged 30-70 years diagnosed with type 2 diabetes mellitus (T2DM) for ≥1 year (fasting glucose ≥126 mg/dL or HbA1c ≥6.5%), assessed for platelet indices (MPV, PDW, etc.), inflammatory markers (hs-CRP, ESR), and glycemic parameters via single blood draw and clinical evaluation; exclusions include type 1 DM, infections, anti-platelet drugs. |
| Healthy Controls | – | –100 healthy adults aged 30-70 years without diabetes or major systemic illness, evaluated similarly for platelet indices, inflammatory markers, and basic glycemic parameters as comparators in this cross-sectional case-control study at Assiut University Hospitals. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200 adults aged 30-70 years recruited from Assiut University Hospitals and clinics: 100 with type 2 diabetes mellitus (T2DM, diagnosed ≥1 year, fasting glucose ≥126 mg/dL or HbA1c ≥6.5%) and 100 healthy controls without diabetes or major illness. Both groups undergo single assessments of platelet indices (MPV, PDW, P-LCR, PCT via CBC), inflammatory markers (hs-CRP, ESR), and glycemic parameters (fasting/postprandial glucose, HbA1c).
Key inclusion criteria (3 listed)
- Adults aged 30-70 years.
- Diagnosed T2DM for at least 1 year.
- Fasting blood glucose ≥126 mg/dL and/or HbA1c ≥ 6.5%
Key exclusion criteria (6 listed)
- Type 1 Diabetes Mellitus
- Acute infection, chronic inflammatory disease
- Malignancy.
- Current use of anti-platelet or anti-inflammatory medications
- Chronic liver, renal, or hematologic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Platelet Volume (MPV)
Time frame: Single measurement at enrollment
Difference in mean platelet volume (MPV) measured from complete blood count between T2DM patients and healthy controls. MPV reflects platelet activation and size, expected to be elevated in T2DM due to inflammation and hyperglycemia.
1 secondary outcome
High-sensitivity C-reactive Protein (hs-CRP)
Time frame: Single measurement at enrollment
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 23 Jan 2026.
Related trials for Platelet Indices
Not yet recruitingObservational study
Platelet Indices and Blood Groups in Type 2 Diabetes Vascular Complications
Type 2 Diabetes Mellitus, Vascular Complications
Not yet recruitingObservational study
Serial Platelet Count and Indices for Predicting In-Hospital Mortality in Sepsis
Sepsis
Not yet recruitingObservational study
CBC-Based Inflammatory Indices in Newly Diagnosed Multiple Myeloma
Multiple Myeloma
Not yet recruitingObservational study
CBC-Derived Inflammatory Indices in Acute Pancreatitis
Acute Pancreatitis, Pancreatitis
Active, not recruitingObservational study
Predictive Value of Nutritional and Inflammatory Indices for Postoperative Complications After Bariatric Surgery
Obesity (BMI > 35), Morbid Obesity
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Platelet Indices and Type 2 Diabetes, 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 3 inclusion and 6 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 23 Jan 2026. 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?
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?
Mean Platelet Volume (MPV) (time frame: Single measurement at enrollment). 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 23 Jan 2026.