NCT04949152

Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,046 (estimated)
• Sponsor: University of Campinas, Brazil · Academic / Other
• Sex: All
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Diabete Mellitus
• Coronary Artery Disease

Timeline

• Start date: 2016-06-01
• Primary completion: 2021-05-31
• Completion: 2026-05-31
• First posted: 2021-07-02
• Last updated: 2021-07-02

Locations

1 site across 1 country: Brazil