Skip to main content
Clinical Trials/NCT06068205
NCT06068205Not yet recruitingNot Applicable

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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS0 sites48 target enrollmentStarted: September 29, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
48
Primary Endpoint
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.

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
50 Years to 70 Years (Adult, Older Adult)
Sex
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/m^2 or < 18.5 Kg/m^2
  • Liver failure
  • Concomitant acute infections
  • Uncontrolled thyroid diseases
  • Pregnancy

Outcomes

Primary Outcomes

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.

Time Frame: 1 day

Young's modulus values are obtained using atomic force microscopy

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Similar Trials

COMPARATIVE ANALYSIS OF THE... | Clinical Trial