Prevalence of microvascular and macrovascular disease in the Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) Study cohort.

The Glycemia Reduction Approaches in Diabetes - A Comparative Effectiveness (GRADE) trial is a randomized clinical trial comparing glycemic effects of four diabetes medications added to metformin in type 2 diabetes (T2D). Microvascular and macrovascular diseases are secondary outcomes. We evaluated the prevalence and risk factor relationships for microvascular and macrovascular complications in the GRADE cohort at study entry. Complication prevalence and risk factors were analyzed based on data from screening in all consenting participants meeting GRADE eligibility. Logistic regression and Z-statistics were used to assess risk factor relationships with complications. We enrolled 5047 T2D participants [mean age 57 years; 36% female; mean known T2D duration 4 years (all < 10 years); mean HbA1c 8.0% (∼64 mmol/mol) at screening]. Urinary albumin/creatinine ratio (ACR) ≥ 30 mg/gram was present in 15.9% participants; peripheral neuropathy (by Michigan Neuropathy Screening Instrument) in 21.5%; cardiovascular autonomic neuropathy by electrocardiography-derived indices in 9.7%; self-reported retinopathy in 1.0%. Myocardial infarction ascertained by self-report or electrocardiogram was present in 7.3%, and self-reported history of stroke in 2.0%. In the GRADE cohort with < 10 years of T2D and a mean HbA1c of 8.0%, diabetes complications were present in a substantial fraction of participants, more so than might otherwise have been expected.

Informations de copyright

Copyright © 2020 Elsevier B.V. All rights reserved.

Déclaration de conflit d'intérêts

Contribution statement All authors affirm that authorship is merited based on the ICMJE authorship criteria. IB, JPC, CD, JBG, HKS, MEL, KJM, RP-B, EBS, and DJW contributed to the conception and design of this manuscript. IB, JPS, CD, JBG, HKS, KJM, JP, ERS, RP-B and EZS contributed to the acquisition of data for this manuscript. IB contributed to the statistical analysis of data for this manuscript. CB, IB, RMC, JPC, CD, JBG, MSK, HKS, KJM, RP-B, ERS, EBS, EZS, and DJW contributed to the interpretation of data and results for this manuscript. CD, KJM, RP-B, and ERS contributed to the supervision and management of research for this manuscript. IB, CD, HKS, HKS, MEL, KJM, and RP-B contributed to the drafting of this manuscript. CB, IB, RMC, JPC, CD, JBG, MSK, HKS, KJM, JP, RP-B, ERS, EBS, EZS, and DJS contributed to the critical review of this manuscript. IB, KJM and RP-B are guarantors of this work, and as such, had full access to all the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis.