Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

NCT ID: NCT04949152

Last Updated: 2021-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1046 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2026-05-31

Brief Summary

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Ongoing prospective cohort of type 2 diabetes individuals.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases Diabete Mellitus Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unconfirmed diagnosis of diabetes
* Intellectual disability
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Campinas, Brazil

OTHER

Sponsor Role lead

Responsible Party

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Andrei Carvalho Sposito

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical research center

Campinas, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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joaquim barreto, MD

Role: primary

+55 19 3521 7959

References

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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.

Reference Type DERIVED
PMID: 36190762 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35174749 (View on PubMed)

Other Identifiers

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41618915.1.0000.5404

Identifier Type: -

Identifier Source: org_study_id

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