Platelet Changes in Type 2 Diabetes

January 15, 2026 updated by: Hagar Hassan Mostafa Ahmed, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

200

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

Yes

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria:

  • Adults aged 30-70 years.
  • Diagnosed T2DM for at least 1 year.
  • Fasting blood glucose ≥126 mg/dL and/or HbA1c ≥ 6.5%

Exclusion Criteria:

  • 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)

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
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single measurement at enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High-sensitivity C-reactive Protein (hs-CRP)
Time Frame: Single measurement at enrollment
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.
Single measurement at enrollment

Collaborators and Investigators

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

Sponsor

Assiut University

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)

February 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Platelet indices in T2DM

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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