Cardiovascular DiseasesBDSNCT04949152
Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort
An observational study of Cardiovascular Diseases and Diabete Mellitus, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Ongoing prospective cohort of type 2 diabetes individuals. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Cardiovascular Diseases, Diabete Mellitus, Coronary Artery Disease
- How many people
- 1,046 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2016to 31 May 2026
- How long will I take part?
- 5 Years
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals from both genders, aged 40 to 70 years-old, with confirmed diagnosis of type 2 diabetes mellitus.
Who may be able to join
- Diagnosed type 2 diabetes
- Age between 40 and 70 years old
Who cannot join
- Unconfirmed diagnosis of diabetes
- Intellectual disability
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinical research center
Campinas, São Paulo, 13083887
joaquim barreto, MD, +55 19 3521 7959, joaquimbarretoantunes@gmail.com
joaquim barreto, md
About this study
Ongoing prospective cohort of type 2 diabetes individuals.
Read the detailed description
The study population included individuals with type 2 diabetes aged between 40 and 70 years old, living in the metropolitan area of Campinas, Brazil. The volunteers were recruited between 2016 and 2020 through radio, newspaper, television and social media advertisements. A total of 1046 participants were enrolled into the study so far.
All participants were firstly invited to an interview with the physician-researcher for medical story register and physical examination. Afterwards, all participants were submitted to the following procedures: blood and urine samples collection, dual-energy X-ray absorptiometry, 6 minutes walk test, hand strength test, bone densitometry test, diabetic polyneuropathy evaluation, advanced glycation end-product measurement, electrocardiogram, echocardiogram, carotid doppler ultrasound, flow-mediated dilation, diabetic retinopathy assessment, ambulatory blood pressure monitoring and cardiac computed tomography for calcium scoring. After full examination, patients were contacted every year for 5 years for endpoints registration. The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke and myocardial revascularization. Secondary endpoints were end-stage kidney disease requiring dialysis and limb amputation. Study data were collected and managed using REDCap electronic data capture tools.
- Keywords
- diabetes, cardiovascular disease
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
All cause death, myocardial infarction, stroke, myocardial revascularization
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jun 2016
- Primary completion31 May 2021
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,046 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrei Carvalho Sposito, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949152
- Sponsor's protocol ID
- 41618915.1.0000.5404
- Acronym
- BDS
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barreto J, Chaves F, Fernandes VHR, Jesus DC, Nascimento MA, Lira RPC, Nadruz W, Arieta C, Sposito AC. Proteinuria in early referral to spectral domain optical coherence tomography for macular edema detection in type 2 diabetes individuals: results from the Brazilian diabetes study. Curr Med Res Opin. 2022 Dec;38(12):2141-2148. doi: 10.1080/03007995.2022.2131302. Epub 2022 Nov 4.
PubMed 36190762Barreto J, Wolf V, Bonilha I, Luchiari B, Lima M, Oliveira A, Vitte S, Machado G, Cunha J, Borges C, Munhoz D, Fernandes V, Kimura-Medorima ST, Breder I, Fernandez MD, Quinaglia T, Oliveira RB, Chaves F, Arieta C, Guerra-Junior G, Avila S, Nadruz W, Carvalho LSF, Sposito AC; Brazilian Heart Study Group. Rationale and design of the Brazilian diabetes study: a prospective cohort of type 2 diabetes. Curr Med Res Opin. 2022 Apr;38(4):523-529. doi: 10.1080/03007995.2022.2043658. Epub 2022 Mar 2.
PubMed 35174749
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort
- ClinicalTrials.gov ID
- NCT04949152
- Acronym / sponsor ID
- BDS / 41618915.1.0000.5404
- Keywords
- diabetes, cardiovascular disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,046 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 2 Jul 2021 (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.
Ongoing prospective cohort of type 2 diabetes individuals.
Detailed description
The study population included individuals with type 2 diabetes aged between 40 and 70 years old, living in the metropolitan area of Campinas, Brazil. The volunteers were recruited between 2016 and 2020 through radio, newspaper, television and social media advertisements. A total of 1046 participants were enrolled into the study so far.
All participants were firstly invited to an interview with the physician-researcher for medical story register and physical examination. Afterwards, all participants were submitted to the following procedures: blood and urine samples collection, dual-energy X-ray absorptiometry, 6 minutes walk test, hand strength test, bone densitometry test, diabetic polyneuropathy evaluation, advanced glycation end-product measurement, electrocardiogram, echocardiogram, carotid doppler ultrasound, flow-mediated dilation, diabetic retinopathy assessment, ambulatory blood pressure monitoring and cardiac computed tomography for calcium scoring. After full examination, patients were contacted every year for 5 years for endpoints registration. The primary endpoint was a composite of all-cause mortality, myocardial infarction, stroke and myocardial revascularization. Secondary endpoints were end-stage kidney disease requiring dialysis and limb amputation. Study data were collected and managed using REDCap electronic data capture tools.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals from both genders, aged 40 to 70 years-old, with confirmed diagnosis of type 2 diabetes mellitus.
Key inclusion criteria (2 listed)
- Diagnosed type 2 diabetes
- Age between 40 and 70 years old
Key exclusion criteria (2 listed)
- Unconfirmed diagnosis of diabetes
- Intellectual disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: 5 years
All cause death, myocardial infarction, stroke, myocardial revascularization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Derived from this study: PubMed 36190762Barreto J, Chaves F, Fernandes VHR, Jesus DC, Nascimento MA, Lira RPC, Nadruz W, Arieta C, Sposito AC. Proteinuria in early referral to spectral domain optical coherence tomography for macular edema detection in type 2 diabetes individuals: results from the Brazilian diabetes study. Curr Med Res Opin. 2022 Dec;38(12):2141-2148. doi: 10.1080/03007995.2022.2131302. Epub 2022 Nov 4.
- Derived from this study: PubMed 35174749Barreto J, Wolf V, Bonilha I, Luchiari B, Lima M, Oliveira A, Vitte S, Machado G, Cunha J, Borges C, Munhoz D, Fernandes V, Kimura-Medorima ST, Breder I, Fernandez MD, Quinaglia T, Oliveira RB, Chaves F, Arieta C, Guerra-Junior G, Avila S, Nadruz W, Carvalho LSF, Sposito AC; Brazilian Heart Study Group. Rationale and design of the Brazilian diabetes study: a prospective cohort of type 2 diabetes. Curr Med Res Opin. 2022 Apr;38(4):523-529. doi: 10.1080/03007995.2022.2043658. Epub 2022 Mar 2.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Diabete Mellitus, run by University of Campinas, Brazil at 1 site in Brazil.
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 2 inclusion and 2 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 2 Jul 2021. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 5 years). 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 NCT04949152, which also lists 2 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 2 Jul 2021.