Platelet Changes in Type 2 Diabetes

NCT07363122 | Not Yet Recruiting

• 1 other identifier: Platelet indices in T2DM
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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. No treatments or extra procedures are involved.

Conditions

Type 2 Diabetes; Inflammatory Markers; Platelet Indices

Keywords

Platelets; Platelet indices; T2DM; Type 2 Diabetes Mellitus; inflammatory markers

Outcome Measures

Primary Outcomes (1)

• 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.

  Single measurement at enrollment

Secondary Outcomes (1)

• High-sensitivity C-reactive Protein (hs-CRP)

  Single measurement at enrollment

Study Arms (2)

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.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Clinical Pathology Department, Assiut University

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 23, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01