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Ongoing prospective cohort of type 2 diabetes individuals.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| MACE | All cause death, myocardial infarction, stroke, myocardial revascularization | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals from both genders, aged 40 to 70 years-old, with confirmed diagnosis of type 2 diabetes mellitus.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical research center | Recruiting | Campinas | São Paulo | 13083887 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36190762 | Derived | Barreto J, Chaves F, Fernandes VHR, Jesus DC, Nascimento MA, Lira RPC, Nadruz W, Arieta C, Sposito AC. Proteinuria in early referral to spectral domain optical coherence tomography for macular edema detection in type 2 diabetes individuals: results from the Brazilian diabetes study. Curr Med Res Opin. 2022 Dec;38(12):2141-2148. doi: 10.1080/03007995.2022.2131302. Epub 2022 Nov 4. | |
| 35174749 |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Derived |
| Barreto J, Wolf V, Bonilha I, Luchiari B, Lima M, Oliveira A, Vitte S, Machado G, Cunha J, Borges C, Munhoz D, Fernandes V, Kimura-Medorima ST, Breder I, Fernandez MD, Quinaglia T, Oliveira RB, Chaves F, Arieta C, Guerra-Junior G, Avila S, Nadruz W, Carvalho LSF, Sposito AC; Brazilian Heart Study Group. Rationale and design of the Brazilian diabetes study: a prospective cohort of type 2 diabetes. Curr Med Res Opin. 2022 Apr;38(4):523-529. doi: 10.1080/03007995.2022.2043658. Epub 2022 Mar 2. |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |