Cardiovascular Risk FactorsUNISCREENNCT05841719
Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases: Feasibility and Acceptability Pilot Study.
A study testing Screening test in people with Cardiovascular Risk Factors and Autoimmune Diseases, run by Emanuele Bosi at 1 site in Italy.
Trial summary
This study represents a model for a public health program based on a general population screening for the most prevalent chronic metabolic, cardiovascular and autoimmune diseases across adulthood, childhood and adolescence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factors, Autoimmune Diseases
- What is being tested?
- Screening test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,535 participants
- Where
- 1 siteItaly
- Study dates
- 22 Apr 2023to 1 Jan 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residency in Cantalupo, locality of the Municipality of Cerro Maggiore (MI)
- Age between 1 and 100 years
- Ability to understand the purpose of the project and to sign the informed consent.
Who cannot join
- No exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General Population Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases (UNISCREEN): Feasibility and Acceptability Pilot Study.
This study represents a model for a public health program based on a general population screening for the most prevalent chronic metabolic, cardiovascular and autoimmune diseases across adulthood, childhood and adolescence. The main purpose is to assess feasibility and acceptability of using a capillary screening for this purpose. Secondly, it will be possibile to identify people at increased risk of developing one of these health conditions as well as those who are at pre-symptomatic clinical stages. Risk assessment is needed to identify prevention strategies; early diagnosis allows to start early treatment interventions aimed at reducing lifetime complications.This interventional study will enroll volunteers from Cantalupo, a locality belonging to the Municipality of Cerro Maggiore (Milan). Participants will be offered to undergo two capillary blood sampling to test blood glucose levels, glycated haemoglobin, total cholesterol, HDL-c, LDL-c, triglycerides and specific antibodies for type 1 diabetes and celiac disease. In case a participant screens positive for type I diabetes and/or celiac disease, they will be subsequently invited to undergo a new confirmatory blood draw on venous blood. Blood pressure will be also measured for each participant
Read the detailed description
This is a low-risk, single-center, interventional study, assessing whether capillary screening for an early staging of the most prevalent chronic metabolic, cardiovascular and autoimmune diseases is feasible at a population-based level. The study will enroll volunteers from Cantalupo, a locality of 3095 inhabitants belonging to the Municipality of Cerro Maggiore (Milan). The main purpose is to assess feasibility and acceptability of using this public intervention. Secondary outcomes are: (i) measurement of the specific disease markers; (ii) estimation of the prevalence of the identified diseases within the population; (iii) estimation of the prevalence of the identified diseases across age classes; (iv) correlation of study disease indicators with demographics, anthropometrics and clinical data of the population , v) multiparametric risk assessment. Participants will be offered to undergo a capillary blood sampling to test blood glucose levels, glycated haemoglobin, total cholesterol , HDL-c, LDL-c, triglycerides, Glutamic Acid Decarboxylase (GADA), Insulinoma-Associated-2/Tyrosine Phosphatase (IA-2A), Insulin (IAA), Zinc Transporter-8 Autoantibodies (ZnT8A) for type I diabetes and tissue transglutaminase antibodies for celiac disease. Glucose and lipid blood levels will be detected at the time of the screening. The results of autoantibodies research for celiac disease and type 1 diabetes will be available within a few days. In case a participant screens positive for type I diabetes and/or celiac disease, they will be subsequently invited to undergo a new confirmatory blood draw on venous blood. Blood pressure will be also measured for each participant.
- Conditions
- Cardiovascular Risk Factors, Autoimmune Diseases
- Being tested
- Screening test
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening testOther
Capillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed.
| Study group | Role | What they receive |
|---|---|---|
| Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI). | Other | capillary sampling and questionnaires to test feasibility and acceptability Receives: Other: Screening test |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility and acceptability
To assess feasibility and acceptability of the screening program
Measured: through study completion, an average of 1 year
blood glucose and lipids level (mg/dl)
Capillary blood sampling will be performed by finger-prick devices.
Measured: through study completion, an average of 1 year
IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)
Capillary blood sampling will be performed by finger-prick devices.
Measured: within a few days
anti-transglutaminase autoantibodies (UA)
Capillary blood sampling will be performed by finger-prick devices.
Measured: through study completion, an average of 1 year
systolic and diastolic blood pressure (mmHg)
Blood pressure measurement will be performed through a sphygmomanometer.
Measured: through study completion, an average of 1 year
HbA1c (mmol/mol)
Glycated hemoglobin will be measured by finger-prick devices.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start22 Apr 2023
- Primary completion31 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorsStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- capillary sampling
- Masking
- None (open label)
- Enrolment
- 1,535 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuele Bosi
- Sponsor type
- University, hospital or other
- Collaborators
- Italian Diabetes Foundation
- Responsible party
- Sponsor-investigator, Emanuele Bosi, IRCCS San Raffaele
- Investigators
- Emanuele Bosi, MD, Principal investigator, San Raffaele Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841719
- Sponsor's protocol ID
- UNISCREEN
- Acronym
- UNISCREEN
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
PubMed 34458905Ziegler AG, Hoffmann GF, Hasford J, Larsson HE, Danne T, Berner R, Penno M, Koralova A, Dunne J, Bonifacio E. Screening for asymptomatic beta-cell autoimmunity in young children. Lancet Child Adolesc Health. 2019 May;3(5):288-290. doi: 10.1016/S2352-4642(19)30028-8. Epub 2019 Feb 10. No abstract available.
PubMed 30745054Ziegler AG, Kick K, Bonifacio E, Haupt F, Hippich M, Dunstheimer D, Lang M, Laub O, Warncke K, Lange K, Assfalg R, Jolink M, Winkler C, Achenbach P; Fr1da Study Group. Yield of a Public Health Screening of Children for Islet Autoantibodies in Bavaria, Germany. JAMA. 2020 Jan 28;323(4):339-351. doi: 10.1001/jama.2019.21565.
PubMed 31990315US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Ebell M, Epling JW Jr, Herzstein J, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Screening for Celiac Disease: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Mar 28;317(12):1252-1257. doi: 10.1001/jama.2017.1462.
PubMed 28350936Angiulli S, Merolla A, Borgonovo E, De Lorenzo R, Spadoni S, Fontana B, Manganaro G, Rela E, Bongiovanni A, Peracino R, Bellino C, Pata G, Bianconi E, Martinenghi S, Ulivi F, Renzi C, Bosi E; UNISCREEN Study Group. Universal capillary screening for chronic autoimmune, metabolic and cardiovascular diseases: feasibility and acceptability of the UNISCREEN study. Front Public Health. 2025 Feb 11;13:1506240. doi: 10.3389/fpubh.2025.1506240. eCollection 2025.
PubMed 40008147Merolla A, De Lorenzo R, Ferrannini G, Renzi C, Ulivi F, Bazzigaluppi E, Lampasona V, Bosi E. Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol. BMJ Open. 2024 Mar 5;14(3):e078983. doi: 10.1136/bmjopen-2023-078983.
PubMed 38448070
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Population Universal Capillary Screening for Chronic Autoimmune, Metabolic and Cardiovascular Diseases (UNISCREEN): Feasibility and Acceptability Pilot Study.
- ClinicalTrials.gov ID
- NCT05841719
- Acronym / sponsor ID
- UNISCREEN / UNISCREEN
- Conditions
- Cardiovascular Risk Factors, Autoimmune Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,535 participants (actual)
- Lead sponsor
- Emanuele BosiUniversity, hospital or other
- Collaborators
- Italian Diabetes Foundation
- Study start
- 22 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 3 May 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.
This study represents a model for a public health program based on a general population screening for the most prevalent chronic metabolic, cardiovascular and autoimmune diseases across adulthood, childhood and adolescence. The main purpose is to assess feasibility and acceptability of using a capillary screening for this purpose. Secondly, it will be possibile to identify people at increased risk of developing one of these health conditions as well as those who are at pre-symptomatic clinical stages. Risk assessment is needed to identify prevention strategies; early diagnosis allows to start early treatment interventions aimed at reducing lifetime complications.This interventional study will enroll volunteers from Cantalupo, a locality belonging to the Municipality of Cerro Maggiore (Milan). Participants will be offered to undergo two capillary blood sampling to test blood glucose levels, glycated haemoglobin, total cholesterol, HDL-c, LDL-c, triglycerides and specific antibodies for type 1 diabetes and celiac disease. In case a participant screens positive for type I diabetes and/or celiac disease, they will be subsequently invited to undergo a new confirmatory blood draw on venous blood. Blood pressure will be also measured for each participant
Detailed description
This is a low-risk, single-center, interventional study, assessing whether capillary screening for an early staging of the most prevalent chronic metabolic, cardiovascular and autoimmune diseases is feasible at a population-based level. The study will enroll volunteers from Cantalupo, a locality of 3095 inhabitants belonging to the Municipality of Cerro Maggiore (Milan). The main purpose is to assess feasibility and acceptability of using this public intervention. Secondary outcomes are: (i) measurement of the specific disease markers; (ii) estimation of the prevalence of the identified diseases within the population; (iii) estimation of the prevalence of the identified diseases across age classes; (iv) correlation of study disease indicators with demographics, anthropometrics and clinical data of the population , v) multiparametric risk assessment. Participants will be offered to undergo a capillary blood sampling to test blood glucose levels, glycated haemoglobin, total cholesterol , HDL-c, LDL-c, triglycerides, Glutamic Acid Decarboxylase (GADA), Insulinoma-Associated-2/Tyrosine Phosphatase (IA-2A), Insulin (IAA), Zinc Transporter-8 Autoantibodies (ZnT8A) for type I diabetes and tissue transglutaminase antibodies for celiac disease. Glucose and lipid blood levels will be detected at the time of the screening. The results of autoantibodies research for celiac disease and type 1 diabetes will be available within a few days. In case a participant screens positive for type I diabetes and/or celiac disease, they will be subsequently invited to undergo a new confirmatory blood draw on venous blood. Blood pressure will be also measured for each participant.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- capillary sampling
| Arm | Type | Receives |
|---|---|---|
| Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI). | Other | Other: Screening testcapillary sampling and questionnaires to test feasibility and acceptability |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Residency in Cantalupo, locality of the Municipality of Cerro Maggiore (MI)
- Age between 1 and 100 years
- Ability to understand the purpose of the project and to sign the informed consent.
Key exclusion criteria (1 listed)
- No exclusion criteria.
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 |
|---|---|---|
| Screening testCapillary blood sampling by finger-prick devices and second confirmatory venous sampling when needed. | Other | Population from Cantalupo, locality of the Municipality of Cerro Maggiore (MI). |
Primary outcome
feasibility and acceptability
Time frame: through study completion, an average of 1 year
To assess feasibility and acceptability of the screening program
blood glucose and lipids level (mg/dl)
Time frame: through study completion, an average of 1 year
Capillary blood sampling will be performed by finger-prick devices.
IAA, GADA65, ZnT8, IA2 autoantibodies (U/ml)
Time frame: within a few days
Capillary blood sampling will be performed by finger-prick devices.
anti-transglutaminase autoantibodies (UA)
Time frame: through study completion, an average of 1 year
Capillary blood sampling will be performed by finger-prick devices.
systolic and diastolic blood pressure (mmHg)
Time frame: through study completion, an average of 1 year
Blood pressure measurement will be performed through a sphygmomanometer.
HbA1c (mmol/mol)
Time frame: through study completion, an average of 1 year
Glycated hemoglobin will be measured by finger-prick devices.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Background: PubMed 34458905Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.
- Background: PubMed 30745054Ziegler AG, Hoffmann GF, Hasford J, Larsson HE, Danne T, Berner R, Penno M, Koralova A, Dunne J, Bonifacio E. Screening for asymptomatic beta-cell autoimmunity in young children. Lancet Child Adolesc Health. 2019 May;3(5):288-290. doi: 10.1016/S2352-4642(19)30028-8. Epub 2019 Feb 10. No abstract available.
- Background: PubMed 31990315Ziegler AG, Kick K, Bonifacio E, Haupt F, Hippich M, Dunstheimer D, Lang M, Laub O, Warncke K, Lange K, Assfalg R, Jolink M, Winkler C, Achenbach P; Fr1da Study Group. Yield of a Public Health Screening of Children for Islet Autoantibodies in Bavaria, Germany. JAMA. 2020 Jan 28;323(4):339-351. doi: 10.1001/jama.2019.21565.
- Background: PubMed 28350936US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Barry MJ, Davidson KW, Doubeni CA, Ebell M, Epling JW Jr, Herzstein J, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Phipps MG, Silverstein M, Simon MA, Tseng CW. Screening for Celiac Disease: US Preventive Services Task Force Recommendation Statement. JAMA. 2017 Mar 28;317(12):1252-1257. doi: 10.1001/jama.2017.1462.
- Derived from this study: PubMed 40008147Angiulli S, Merolla A, Borgonovo E, De Lorenzo R, Spadoni S, Fontana B, Manganaro G, Rela E, Bongiovanni A, Peracino R, Bellino C, Pata G, Bianconi E, Martinenghi S, Ulivi F, Renzi C, Bosi E; UNISCREEN Study Group. Universal capillary screening for chronic autoimmune, metabolic and cardiovascular diseases: feasibility and acceptability of the UNISCREEN study. Front Public Health. 2025 Feb 11;13:1506240. doi: 10.3389/fpubh.2025.1506240. eCollection 2025.
- Derived from this study: PubMed 38448070Merolla A, De Lorenzo R, Ferrannini G, Renzi C, Ulivi F, Bazzigaluppi E, Lampasona V, Bosi E. Universal screening for early detection of chronic autoimmune, metabolic and cardiovascular diseases in the general population using capillary blood (UNISCREEN): low-risk interventional, single-centre, pilot study protocol. BMJ Open. 2024 Mar 5;14(3):e078983. doi: 10.1136/bmjopen-2023-078983.
- Individual participant dataSharing planned: No
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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.
Emanuele Bosi, MD principal investigator
San Raffaele Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening test in people with Cardiovascular Risk Factors and Autoimmune Diseases, run by Emanuele Bosi at 1 site in Italy.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
feasibility and acceptability (time frame: through study completion, an average of 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05841719, which also lists 6 linked publications.
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 6 Mar 2024; AzTrials last refreshed its copy on 7 Nov 2026.