Brazilian Diabetes Study: a Type 2 Diabetes Prospective Cohort

  • STATUS
    Recruiting
  • End date
    May 31, 2026
  • participants needed
    1046
  • sponsor
    University of Campinas, Brazil
Updated on 10 July 2021
diabetes

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.

Details
Condition Diabetes Mellitus Types I and II, Coronary heart disease, cardiovascular diseases, Diabetes Mellitus, Cardiac Ischemia, Diabetes (Pediatric), Coronary Artery Disease, Cardiovascular Disease, cardiovascular system diseases, diabetes mellitus (dm), Myocardial Ischemia, Diabetes Prevention, cardiovascular disorders, cardiovascular disease (cvd)
Clinical Study IdentifierNCT04949152
SponsorUniversity of Campinas, Brazil
Last Modified on10 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed type 2 diabetes
Age between 40 and 70 years old

Exclusion Criteria

Unconfirmed diagnosis of diabetes
Intellectual disability
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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