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NCT Number: NCT07363122

Platelet Changes in Type 2 Diabetes

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Platelet Indices Changes in Type 2 Diabetes Mellitus and Their Relationship With Inflammatory Markers

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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