Kieren J Mather1, Ionut Bebu2, Chelsea Baker3, Robert M Cohen4, Jill P Crandall5, Cyrus DeSouza6, Jennifer B Green7, M Sue Kirkman8, Heidi Krause-Steinrauf9, Mary Larkin10, Jeremy Pettus11, Elizabeth R Seaquist12, Elsayed Z Soliman13, Emily B Schroeder14, Deborah J Wexler10, Rodica Pop-Busui15. 1. Division of Endocrinology & Metabolism, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, United States. 2. The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD, United States. Electronic address: grademail@bsc.gwu.edu. 3. Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, Aurora, CO, United States. 4. Division of Endocrinology, Diabetes & Metabolism, Department of Medicine, University of Cincinnati College of Medicine & Endocrine Section, Cincinnati VA Medical Center, Cincinnati OH, United States. 5. Division of Endocrinology and Fleischer Institute for Diabetes & Metabolism, Albert Einstein College of Medicine, Bronx, NY, United States. 6. Division of Diabetes, Endocrinology & Metabolism, University of Nebraska College of Medicine, Omaha, NE, United States. 7. Division of Endocrinology, Department of Medicine, Duke University Medical Center, Durham, NC, United States. 8. Division of Endocrinology & Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, United States. 9. The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD, United States. 10. Massachusetts General Hospital Diabetes Center and Harvard Medical School, Boston, MA, United States. 11. Division of Endocrinology & Metabolism, Department of Medicine, University of California, San Diego, CA, United States. 12. Division of Diabetes and Endocrinology, Department of Medicine, University of Minnesota Medical School, Minneapolis, MN, United States. 13. Epidemiological Cardiology Research Center, Department of Epidemiology and Prevention and Department of Internal Medicine-Cardiology Section, Wake Forest School of Medicine, Winston Salem, NC, United States. 14. Institute for Health Research, Kaiser Permanente Colorado, Aurora, CO, United States. 15. Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, United States.
Abstract
AIMS: 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. METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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.
AIMS: 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. METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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.
Authors: Michael A Grassi; D Anthony Mazzulla; Michael D Knudtson; Wendy W Huang; Kristine E Lee; Barbara E Klein; Dan L Nicolae; Ronald Klein Journal: Am J Ophthalmol Date: 2008-12-03 Impact factor: 5.258
Authors: Andrew S Levey; Lesley A Stevens; Christopher H Schmid; Yaping Lucy Zhang; Alejandro F Castro; Harold I Feldman; John W Kusek; Paul Eggers; Frederick Van Lente; Tom Greene; Josef Coresh Journal: Ann Intern Med Date: 2009-05-05 Impact factor: 25.391
Authors: Katherine R Tuttle; George L Bakris; Rudolf W Bilous; Jane L Chiang; Ian H de Boer; Jordi Goldstein-Fuchs; Irl B Hirsch; Kamyar Kalantar-Zadeh; Andrew S Narva; Sankar D Navaneethan; Joshua J Neumiller; Uptal D Patel; Robert E Ratner; Adam T Whaley-Connell; Mark E Molitch Journal: Diabetes Care Date: 2014-10 Impact factor: 19.112
Authors: Aleksandra Klisic; Irena Radoman Vujacic; Jelena Munjas; Ana Ninic; Jelena Kotur-Stevuljevic Journal: Arch Med Sci Date: 2022-04-10 Impact factor: 3.707
Authors: Christian S Hansen; Tommi Suvitaival; Simone Theilade; Ismo Mattila; Maria Lajer; Kajetan Trošt; Linda Ahonen; Tine W Hansen; Cristina Legido-Quigley; Peter Rossing; Tarunveer S Ahluwalia Journal: Front Endocrinol (Lausanne) Date: 2022-04-14 Impact factor: 6.055
Authors: Rodica Pop-Busui; Jye-Yu C Backlund; Ionut Bebu; Barbara H Braffett; Gayle Lorenzi; Neil H White; John M Lachin; Elsayed Z Soliman Journal: J Diabetes Investig Date: 2021-08-14 Impact factor: 4.232