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

September 28, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects with type I diabetes mellitus with (case group) and without (control group) microvascular complications. The two groups will be balanced for age (50-70 years), age of disease (>10 years), glycaemic control and BMI value.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 29, 2023

Primary Completion (Estimated)

July 29, 2025

Study Completion (Estimated)

September 29, 2025

Study Registration Dates

First Submitted

September 28, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 5, 2023

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

September 28, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5860

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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