Platelet Changes in Type 2 Diabetes

Assiut University

Status: Not yet enrolling

Conditions: Inflammatory Markers; Type 2 Diabetes; Platelet Indices

Study type: Observational

Funder types: Other

Identifiers

NCT07363122

Platelet indices in T2DM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

200 participants in 2 patient groups

T2DM Patients

Description:

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

Description:

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.