Rationale and design of the Brazilian diabetes study: a prospective cohort of type 2 diabetes

Oliveira, Joaquim; Wolf, Vaneza Lira Waldow; Bonilha, Isabella; Luchiari, Beatriz; Lima, Marcus; Oliveira, A. N.; Vitte, Sofia; Machado, Gabriela; Cunha, Jessica; Borges, Cynthia; Munhoz, Daniel; Fernandes, Vicente; Kimura-Medorima, Sheila T.; Breder, Íkaro; Fernandez, Marta Duran; Quinaglia, Thiago; Oliveira, Rodrigo Bueno de; Chaves, Fernando Rodrigo Pedreira; Arieta, Carlos Eduardo Leite; Guerra, Gil; Avila, Sandra; Nadruz, Wilson; Carvalho, Luiz Sérgio F.; Sposito, Andrei C.

doi:10.1080/03007995.2022.2043658

Cited by 7 publications

(4 citation statements)

References 35 publications

(22 reference statements)

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“…This analysis included all cohort who ophthalmological examinations, including fundus examination, and had at least two measurements of glycated hemoglobin (HbA1c). The local ethics committee approved the study (CAEE: 89525518.8.1001.5404), and all patients signed an informed consent form and signed an informed consent form 10 .…”

Section: Methodsmentioning

confidence: 99%

Long‑term HbA1c variability predicts diabetic retinopathy in patients with type 2 diabetes: results from the Brazilian Diabetes Study

de jesus,

Barreto,

Chaves

et al. 2024

Preprint

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Background: Diabetic retinopathy (DR) is the leading cause of blindness in working-age patients. Although prior studies revealed hyperglycemia as an imperative marker of diabetic retinopathy risk, whether glycemic variability imposes an increased risk of retinopathy remains unclear. As retinopathy is often diagnosed at later stages, when the potential benefit of intervention is significantly attenuated, assessing glycemic variability as an added source when selecting diabetes patients for earlier referral for ophthalmological evaluation may assist in preventing disability. To evaluate this hypothesis, this study investigated the relationship between glycemic variability parameters and diabetic retinopathy using data from a local cohort of patients with type 2 diabetes. Basic procedures. This study included cohort members aged 18 years and older who had undergone ophthalmological examinations, including retinography and visual acuity testing, and who had at least two glycemic hemoglobin measurements throughout their participation in the study. The Early Treatment Diabetic Retinopathy Study (ETDRS)criteria were used to classify diabetic retinopathy. Using validated methods, glycemic variability was calculated as the standard deviation and mean amplitude of glycemic excursions. Main findings: In the studied included 238 patients, 22% of individuals with type 2 diabetes mellitus (T2DM) had DR. Each 1% increase in baseline HbA1c was related to a 44% greater risk of diabetic retinopathy (OR 1.44, 95% CI 1.190–1.754, p 0.001). A one-unit increase in the standard deviation of HbA1c was associated with a 74% increased risk of DR (OR 1.74, 95% CI 1.067–2.847; p 0.027). Principal conclusions: Glycated hemoglobin variability, measured as the standard deviation of repeated measures, was independently related to diabetic retinopathy risk (Clinicaltrials.gov: NCT04949152).

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Section: Methodsmentioning

confidence: 99%

Long‑term HbA1c variability predicts diabetic retinopathy in patients with type 2 diabetes: results from the Brazilian Diabetes Study

de jesus,

Barreto,

Chaves

et al. 2024

Preprint

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“…8 Participants of the control group were consecutively recruited from an ongoing, local cohort of type 2 diabetes held by our research center, and their selection prioritized patients of similar age and sex as reported in the kidney failure group. 9…”

Section: Study Populationmentioning

confidence: 99%

Pharmacokinetic Properties of Dapagliflozin in Hemodialysis and Peritoneal Dialysis Patients

Barreto

Borges

Rodrigues

et al. 2023

CJASN

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Background Sodium-glucose cotransporter 2 (SGLT2) inhibitors attenuate incident cardiovascular outcomes, irrespective of baseline GFR, in conservatively managed CKD. As this condition inexorably progresses to demanding KRT, drug withdrawal is supported by the current lack of evidence of safety of SGLT2 inhibitors in dialysis. Methods This study was a prospective, single-center, open-label trial (ClinicalTrials.gov identifier: NCT05343078) aimed at assessing the pharmacokinetic properties and safety of dapagliflozin in patients with kidney failure on regular dialysis regimens compared with those with type 2 diabetes and age- and sex-matched controls with normal kidney function. Peripheral blood samples were collected from both groups every 30 minutes for 4 hours and again after 48 hours after ingestion of dapagliflozin 10 mg, which occurred immediately before dialysis session initiation in the kidney failure group. This protocol occurred in drug-naïve patients and again after six daily doses of dapagliflozin to assess whether the drug had accumulated. The plasma and dialysate levels of dapagliflozin at each time point were determined by liquid chromatography and used to calculate pharmacokinetics parameters (peak concentration [Cmax] and area under the plasma concentration-versus-time curve) for each participant. Results Dapagliflozin Cmax was 117 and 97.6 ng/ml in the kidney failure and control groups, respectively, whereas the corresponding accumulation ratios were 26.7% and 9.5%. No serious adverse events were reported for either group. Dapagliflozin recovered from dialysate corresponded to 0.10% of the administered dose. Conclusions In patients with kidney failure on dialysis, dapagliflozin was well tolerated, was slightly dialyzable, and had nonaccumulating pharmacokinetic properties. Clinical Trial registry name and registration number: Pharmacokinetics and Dialyzability of Dapagliflozin in Dialysis Patients (DARE-ESKD 1), NCT05343078

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“…On this occasion, patients underwent SBP measurement [23], ophthalmological examination [24], and peripheral blood and urine sample collection for biochemical analysis. The study design has been detailed elsewhere [25].…”

Section: Study Populationmentioning

confidence: 99%

Compliance with Cardiovascular Prevention Guidelines in Type 2 Diabetes Individuals in a Middle-Income Region: A Cross-Sectional Analysis

et al. 2022

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Stricter control of risk factors has been pursued as a compelling strategy to mitigate cardiovascular events (CVE) in type 2 diabetes (T2D) individuals. However, the achievement rate of the recommended goals has remained low in clinical practice. This study investigated the 2019 ESC guideline recommendation attainment among T2D individuals enrolled in a national cohort held in Brazil. Data from 1030 individuals (mean age: 58 years old; 54% male; mean T2D duration: 9.7 years) were analyzed. The control rates were 30.6% for SBP, 18.8% for LDL-C, and 41% for A1c, and only 3.2% of the study participants met all three targets. Statins and high-intensity lipid-lowering therapy prescription rates were 45% and 8.2%, respectively. Longer T2D duration and those at higher CV risk were less likely to be controlled. Longer diabetes duration and higher CV risk were inversely related to the chance of achieving the recommended targets. Treatment escalation using conventional therapies would be sufficient to gain optimal control in most of the study sample. In conclusion, a minimal proportion of T2D individuals comply with guidelines-oriented CV prevention targets. Given the significant burden of the disease, and the substantial effect size predicted for these therapies, bridging this gap between guidelines and clinical practice should be considered an urgent call to public health managers.

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Rationale and design of the Brazilian diabetes study: a prospective cohort of type 2 diabetes

Cited by 7 publications

References 35 publications

Long‑term HbA1c variability predicts diabetic retinopathy in patients with type 2 diabetes: results from the Brazilian Diabetes Study

Long‑term HbA1c variability predicts diabetic retinopathy in patients with type 2 diabetes: results from the Brazilian Diabetes Study

Pharmacokinetic Properties of Dapagliflozin in Hemodialysis and Peritoneal Dialysis Patients

Compliance with Cardiovascular Prevention Guidelines in Type 2 Diabetes Individuals in a Middle-Income Region: A Cross-Sectional Analysis

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