COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
1 other identifier
observational
48
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Sep 2023
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2023
CompletedStudy Start
First participant enrolled
September 29, 2023
CompletedFirst Posted
Study publicly available on registry
October 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2025
CompletedOctober 5, 2023
September 1, 2023
1.8 years
September 28, 2023
September 28, 2023
Conditions
Outcome Measures
Primary Outcomes (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.
Young's modulus values are obtained using atomic force microscopy
1 day
Study Arms (2)
Type 1 diabetes with microvascular complications
Type 1 diabetes without microvascular complications
Interventions
A single blood test to be analysed through atomic force microscopy in the force spectroscopy mode
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2023
First Posted
October 5, 2023
Study Start
September 29, 2023
Primary Completion
July 29, 2025
Study Completion
September 29, 2025
Last Updated
October 5, 2023
Record last verified: 2023-09