Diabetes Mellitus, Type 1NCT06068205
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
An observational study of Diabetes Mellitus, Type 1, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Blood test - atomic force microscopy in the force spectroscopy mode
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- 29 Sep 2023to 29 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Blood test - atomic force microscopy in the force spectroscopy mode
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test - atomic force microscopy in the force spectroscopy modeDiagnostic test
A single blood test to be analysed through atomic force microscopy in the force spectroscopy mode
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes with microvascular complications | Not described Receives: Diagnostic Test: Blood test - atomic force microscopy in the force spectroscopy mode | |
| Type 1 diabetes without microvascular complications | Not described Receives: Diagnostic Test: Blood test - atomic force microscopy in the force spectroscopy mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start29 Sep 2023 (estimated)
- Primary completion29 Jul 2025 (estimated)
- Study completion29 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068205
- Sponsor's protocol ID
- 5860
- Status last verified
- Sep 2023
- First submitted
- 28 Sep 2023
- Last updated
- 5 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
- ClinicalTrials.gov ID
- NCT06068205
- Acronym / sponsor ID
- 5860
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 29 Sep 2023 (estimated)
- Primary completion
- 29 Jul 2025 (estimated)
- Study completion
- 29 Sep 2025 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes with microvascular complications | – | Diagnostic Test: Blood test - 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 |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test - atomic force microscopy in the force spectroscopy modeA single blood test to be analysed through atomic force microscopy in the force spectroscopy mode | Diagnostic test | Type 1 diabetes with microvascular complications, Type 1 diabetes without microvascular complications |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dario Pitocco (+390630154071, dario.pitocco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.