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

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06068205
Collaborator
(none)
48
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Blood test - atomic force microscopy in the force spectroscopy mode

Study Design

Study Type:
Observational
Anticipated Enrollment :
48 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
Anticipated Study Start Date :
Sep 29, 2023
Anticipated Primary Completion Date :
Jul 29, 2025
Anticipated Study Completion Date :
Sep 29, 2025

Arms and Interventions

Arm Intervention/Treatment
Type 1 diabetes with microvascular complications

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
Type 1 diabetes without microvascular complications

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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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/m2 or < 18.5 Kg/m2

  • Liver failure

  • Concomitant acute infections

  • Uncontrolled thyroid diseases

  • Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT06068205
Other Study ID Numbers:
  • 5860
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Sep 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Oct 5, 2023