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

NCT ID: NCT06068205

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-29

Study Completion Date

2025-09-29

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 1

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Type 1 diabetes with microvascular complications

Blood test - atomic force microscopy in the force spectroscopy mode

Intervention Type DIAGNOSTIC_TEST

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

Type 1 diabetes without microvascular complications

Blood test - atomic force microscopy in the force spectroscopy mode

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Dario Pitocco

Role: CONTACT

+390630154071

Other Identifiers

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5860

Identifier Type: -

Identifier Source: org_study_id

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