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NCT06068205 Clinical Trial

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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06068205
Other study ID # 5860
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 29, 2023
Est. completion date September 29, 2025

Study information
Verified date September 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact Dario Pitocco
Phone +390630154071
Email dario.pitocco@policlinicogemelli.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome
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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