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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06068205
Enrollment
48
Registered
2023-10-05
Start date
2023-09-29
Completion date
2025-09-29
Last updated
2023-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

DIAGNOSTIC_TESTBlood test - atomic force microscopy in the force spectroscopy mode

A single blood test to be analysed through atomic force microscopy in the force spectroscopy mode

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 dayYoung's modulus values are obtained using atomic force microscopy

Contacts

Primary ContactDario Pitocco
dario.pitocco@policlinicogemelli.it+390630154071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026