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RecruitingNCT04949152BDSUpdated Jul 2, 2021

Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

An observational study in Cardiovascular Diseases, Diabete Mellitus and Coronary Artery Disease, sponsored by University of Campinas, Brazil. Recruiting at 1 site in Brazil. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-07-02.

Sponsored by University of Campinas, Brazil · Observational

From the registry’s dates

  • Started Jun 2016; still recruiting 10 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,046
Ages
40 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cardiovascular Diseases
  • Diabete Mellitus
  • Coronary Artery Disease

Keywords

  • diabetes
  • cardiovascular disease
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 1,046 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals from both genders, aged 40 to 70 years-old, with confirmed diagnosis of type 2 diabetes mellitus.

Inclusion criteria

  • Diagnosed type 2 diabetes
  • Age between 40 and 70 years old

Exclusion criteria

Exclusion Criteria:

  • Unconfirmed diagnosis of diabetes
  • Intellectual disability
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,046 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. MACE

    All cause death, myocardial infarction, stroke, myocardial revascularization

    Time frame: 5 years

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Study locations

1 of 1 sites recruiting
  • Clinical research center
    Campinas, Sp 13083887, Brazil
    • joaquim barreto, MD · Contact · joaquimbarretoantunes@gmail.com · +55 19 3521 7959
    • joaquim barreto, md · Sub investigator
    • andrei c sposito, md, phd · Principal investigator
    • vaneza lira wolf, msc · Sub investigator
    • ikaro breder, md · Sub investigator
    • luiz sergio f carvalho, md, phd · Sub investigator
    Recruiting
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References and documents

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 36190762 ↗
  • Barreto 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04949152
Lead sponsor
University of Campinas, Brazil
Responsible party
Andrei Carvalho Sposito (MD, PhD, University of Campinas, Brazil) — Principal investigator
First posted
Jul 2, 2021
Start date
Jun 1, 2016
Primary completion
May 31, 2021
Completion
May 31, 2026 (estimated)
Last update
Jul 2, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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