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

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Diagnostic Test: Blood test - atomic force microscopy in the force spectroscopy mode

• Registration Number: NCT06068205
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-28
• Study First Submitted QC: 2023-09-28
• Last Update Submitted: 2023-09-28
• Study Start: 2023-09-29
• Study First Posted: 2023-10-05
• Last Update Posted: 2023-10-05
• Primary Completion: 2025-07-29
• Study Completion: 2025-09-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 diabetes without microvascular complications	Blood test - atomic force microscopy in the force spectroscopy mode	-
Type 1 diabetes with microvascular complications	Blood test - atomic force microscopy in the force spectroscopy mode	-

Primary Outcome Measures

Name	Time	Method
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.	1 day	Young's modulus values are obtained using atomic force microscopy