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Clinical Trials/NCT04949152
NCT04949152RecruitingNot Applicable

Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

University of Campinas, Brazil1 site in 1 country1,046 target enrollmentStarted: June 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
1,046
Locations
1
Primary Endpoint
MACE

Study Overview

Brief Summary

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
40 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Unconfirmed diagnosis of diabetes
  • Intellectual disability

Outcomes

Primary Outcomes

MACE

Time Frame: 5 years

All cause death, myocardial infarction, stroke, myocardial revascularization

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Campinas, Brazil
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Andrei Carvalho Sposito

MD, PhD

University of Campinas, Brazil

Study Sites (1)

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