Diabetes Mellitus, Type 1 Clinical Trial
Official title:
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
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.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | September 29, 2025 |
Est. primary completion date | July 29, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 70 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In 48 subjects with type 1 diabetes with and without microvascular complications, the average stiffness of red blood cells, measured using atomic force microscope and quantified using Young's modulus, will be measured. | Young's modulus values are obtained using atomic force microscopy | 1 day |
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