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NCT04949152 Clinical Trial

Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

Coronary Artery Disease Clinical Trial

— BDS  

Official title:
Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04949152
Other study ID # 41618915.1.0000.5404
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date May 31, 2026

Study information
Verified date June 2021
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Ongoing prospective cohort of type 2 diabetes individuals.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1046
Est. completion date May 31, 2026
Est. primary completion date May 31, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - Diagnosed type 2 diabetes - Age between 40 and 70 years old Exclusion Criteria: - Unconfirmed diagnosis of diabetes - Intellectual disability

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Brazil Clinical research center Campinas Sp

Sponsors (1)
Lead Sponsor Collaborator
University of Campinas, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary MACE All cause death, myocardial infarction, stroke, myocardial revascularization 5 years
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