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.