Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

Recruiting

• Conditions: Coronary Artery Disease; Cardiovascular Diseases; Diabete Mellitus

• Registration Number: NCT04949152
• Lead Sponsor: University of Campinas, Brazil

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 Timeline

• Study Start: 2016-06-01
• Primary Completion: 2021-05-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-06-25
• Last Update Submitted: 2021-06-25
• Study First Posted: 2021-07-02
• Last Update Posted: 2021-07-02
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1046

Inclusion Criteria

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

Exclusion Criteria

• Unconfirmed diagnosis of diabetes
• Intellectual disability

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MACE	5 years	All cause death, myocardial infarction, stroke, myocardial revascularization

Trial Locations

Locations (1)

Clinical research center; 🇧🇷 Campinas, Sp, Brazil