COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 1

Treatments: Diagnostic Test: Blood test - atomic force microscopy in the force spectroscopy mode

Study type: Observational

Funder types: Other

Identifiers

NCT06068205

5860

Details and patient eligibility

About

The aim of the study is to analyse the biomechanical stiffness of red blood cells extracted from subjects with type I diabetes with and without microvascular complications through a biophysical characterization of red blood cells using microscopy, spectroscopy and scattering measurements. 48 subjects with type 1 diabetes, 24 with and 24 without microvascular complications will be enrolled. From all subjects a single blood sample will be taken to perform the analysis of red blood cells morpho-mechanical properties.

Enrollment: 48 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of type 1 diabetes for at least 10 years
• Stable metabolic control (HbA1c <7.5%) for at least 6 months
• BMI between 18.5 and 30 Kg/m^2
• Systolic blood pressure < 140 mmHg and diastolic blood pressure <90 mmHg

Exclusion criteria

• Blood pressure higher than 140/90 mmHg
• Unstable metabolic control (HbA1c >7.5%)
• BMI > 30 Kg/m^2 or < 18.5 Kg/m^2
• Liver failure
• Concomitant acute infections
• Uncontrolled thyroid diseases
• Pregnancy

Trial design

48 participants in 2 patient groups

Type 1 diabetes with microvascular complications

Treatment:

Diagnostic Test: Blood test - atomic force microscopy in the force spectroscopy mode

Type 1 diabetes without microvascular complications

Treatment:

Diagnostic Test: Blood test - atomic force microscopy in the force spectroscopy mode