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Photo for ACCORDION Action to Control CV Risks in Diabetes Followup

ACCORDION Action to Control CV Risks in Diabetes Followup

Official Title

ACCORDION (the ACCORD Follow-up Study)

Status

Completed

Overview

To elucidate and clarify the long-term effects of the ACCORD treatment strategies and provide additional data on the long-term relationships among various cardiovascular and diabetic risk factors.

Study Design

Prospective, observational follow-up

Primary Endpoint

The primary endpoint for ACCORDION is the composite outcome of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

Number of Patients

6209

Number of Sites

72

Number of Countries

2

Study Period

2011–2014

Principal Investigator

Hertzel Gerstein

Program Manager

Tara McCready

Research Coordinator

Stephanie Hall

Key Publications

  • ACCORD Study Group. The ACCORD trial: A multidisciplinary approach to control cardiovascular risk in Type 2 diabetes mellitus. Practical Diabet 2004;23:1-7.
  • Simons-Morton DG, Genuth S, Byington RP, Gerstein HC, Friedewald WT. The burden of treatment failure in type 2 diabetes: response to Brown et al. Diabetes Care 2005;28:761-2.
  • Accord Study Group, Buse JB, Bigger JT, et al. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol 2007;99:21i-33i.
  • Bonds DE, Kurashige EM, Bergenstal R, et al. Severe hypoglycemia monitoring and risk management procedures in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 2007;99:80i-9i.
  • Buse JB, Bigger JT, Byington RP, et al. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: design and methods. Am J Cardiol 2007;99:21i-33i.
  • Chew EY, Ambrosius WT, Howard LT, et al. Rationale, design, and methods of the Action to Control Cardiovascular Risk in Diabetes Eye Study (ACCORD-EYE). Am J Cardiol 2007;99:103i-11i.
  • Cushman WC, Grimm RH, Jr., Cutler JA, et al. Rationale and design for the blood pressure intervention of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 2007;99:44i-55i.
  • Gerstein HC, Riddle MC, Kendall DM, et al. Glycemia treatment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 2007;99:34i-43i.
  • Ginsberg HN, Bonds DE, Lovato LC, et al. Evolution of the lipid trial protocol of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 2007;99:56i-67i.
  • Goff DC, Jr., Gerstein HC, Ginsberg HN, et al. Prevention of cardiovascular disease in persons with type 2 diabetes mellitus: current knowledge and rationale for the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 2007;99:4i-20i.
  • Kingry C, Bastien A, Booth G, et al. Recruitment strategies in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Am J Cardiol 2007;99:68i-79i.
  • Sullivan MD, Anderson RT, Aron D, et al. Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design. Am J Cardiol 2007;99:90i-102i.
  • Williamson JD, Miller ME, Bryan RN, et al. The Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Study (ACCORD-MIND): rationale, design, and methods. Am J Cardiol 2007;99:112i-22i.
  • Gerstein HC, Miller ME, Byington RP, et al. Effects of intensive glucose lowering in type 2 diabetes. N Engl J Med 2008;358:2545-59.
  • Herskovits EH, Bryan RN, Yang F. Automated Bayesian segmentation of microvascular white-matter lesions in the ACCORD-MIND study. Advances in medical sciences 2008;53:182-90.
  • Lao Z, Shen D, Liu D, et al. Computer-assisted segmentation of white matter lesions in 3D MR images using support vector machine. Academic radiology 2008;15:300-13.
  • McDuffie R, Summerson J, Reilly P, et al. The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial and Hurricane Katrina: lessons for managing clinical trials during and after a natural disaster. Contemporary clinical trials 2008;29:756-61.
  • Simons-Morton DG. The glycemia-cardiovascular disease hypothesis. Clinical and translational science 2008;1:185-6.
  • Skyler JS, Bergenstal R, Bonow RO, et al. Intensive Glycemic Control and the Prevention of Cardiovascular Events: Implications of the ACCORD, ADVANCE, and VA Diabetes Trials. Diabetes Care 2008.
  • Control Group, Turnbull FM, Abraira C, et al. Intensive glucose control and macrovascular outcomes in type 2 diabetes. Diabetologia 2009;52:2288-98.
  • Mount DL, Feeney P, Fabricatore AN, et al. Constructing common cohorts from trials with overlapping eligibility criteria: implications for comparing effect sizes between trials. Clin Trials 2009;6:416-29.
  • Preiss D, Sattar N. Lipids, lipid modifying agents and cardiovascular risk: a review of the evidence. Clinical endocrinology 2009;70:815-28.
  • Ambrosius WT, Danis RP, Goff DC, Jr., et al. Lack of association between thiazolidinediones and macular edema in type 2 diabetes: the ACCORD eye substudy. Archives of ophthalmology 2010;128:312-8.
  • Bonds DE, Miller ME, Bergenstal RM, et al. The association between symptomatic, severe hypoglycaemia and mortality in type 2 diabetes: retrospective epidemiological analysis of the ACCORD study. BMJ 2010;340:b4909.
  • Calles-Escandon J, Lovato LC, Simons-Morton DG, et al. Effect of intensive compared with standard glycemia treatment strategies on mortality by baseline subgroup characteristics: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Diabetes Care 2010;33:721-7.
  • Chew EY, Ambrosius WT, Davis MD, et al. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med 2010;363:233-44.
  • Cushman WC, Evans GW, Byington RP, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575-85.
  • Ginsberg HN, Elam MB, Lovato LC, et al. Effects of combination lipid therapy in type 2 diabetes mellitus. N Engl J Med 2010;362:1563-74.
  • Group AS, Cushman WC, Evans GW, et al. Effects of intensive blood-pressure control in type 2 diabetes mellitus. N Engl J Med 2010;362:1575-85.
  • Group AS, Group AES, Chew EY, et al. Effects of medical therapies on retinopathy progression in type 2 diabetes. N Engl J Med 2010;363:233-44.
  • Hirsch HA, Iliopoulos D, Joshi A, et al. A transcriptional signature and common gene networks link cancer with lipid metabolism and diverse human diseases. Cancer Cell 2010;17:348-61.
  • Ismail-Beigi F, Craven T, Banerji MA, et al. Effect of intensive treatment of hyperglycaemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomised trial. Lancet 2010;376:419-30.
  • Miller ME, Bonds DE, Gerstein HC, et al. The effects of baseline characteristics, glycaemia treatment approach, and glycated haemoglobin concentration on the risk of severe hypoglycaemia: post hoc epidemiological analysis of the ACCORD study. BMJ 2010;340:b5444.
  • Pop-Busui R, Evans GW, Gerstein HC, et al. Effects of cardiac autonomic dysfunction on mortality risk in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial. Diabetes Care 2010;33:1578-84.
  • Riddle MC. Counterpoint: Intensive glucose control and mortality in ACCORD–still looking for clues. Diabetes Care 2010;33:2722-4.
  • Riddle MC, Ambrosius WT, Brillon DJ, et al. Epidemiologic relationships between A1C and all-cause mortality during a median 3.4-year follow-up of glycemic treatment in the ACCORD trial. Diabetes Care 2010;33:983-90.
  • Anderson RT, Narayan KM, Feeney P, et al. Effect of intensive glycemic lowering on health-related quality of life in type 2 diabetes: ACCORD trial. Diabetes Care 2011;34:807-12.
  • Chew EY, Ambrosius WT. Update of the ACCORD Eye Study. N Engl J Med 2011;364:188-9.
  • Gerstein HC, Miller ME, Genuth S, et al. Long-term effects of intensive glucose lowering on cardiovascular outcomes. N Engl J Med 2011;364:818-28.
  • Ismail-Beigi F. Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial–clinical implications. Clin Chem 2011;57:261-3.
  • Launer LJ, Miller ME, Williamson JD, et al. Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy. Lancet Neurol 2011;10:969-77.
  • Murray AM, Barzilay JI, Lovato JF, et al. Biomarkers of renal function and cognitive impairment in patients with diabetes. Diabetes Care 2011;34:1827-32.
  • Mychaleckyj JC, Farber EA, Chmielewski J, et al. Buffy coat specimens remain viable as a DNA source for highly multiplexed genome-wide genetic tests after long term storage. Journal of translational medicine 2011;9:91.
  • Thethi T, Rajapurkar M, Walker P, et al. Urinary catalytic iron in patients with type 2 diabetes without microalbuminuria–a substudy of the ACCORD Trial. Clin Chem 2011;57:341-4.
  • Ali MK, Feeney P, Hire D, et al. Glycaemia and correlates of patient-reported outcomes in ACCORD trial participants. Diabet Med 2012;29:e67-74.
  • Barzilay JI, Howard AG, Evans GW, et al. Intensive blood pressure treatment does not improve cardiovascular outcomes in centrally obese hypertensive individuals with diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Blood Pressure Trial. Diabetes Care 2012;35:1401-5.
  • Bonds DE, Craven TE, Buse J, et al. Fenofibrate-associated changes in renal function and relationship to clinical outcomes among individuals with type 2 diabetes: the Action to Control Cardiovascular Risk in Diabetes (ACCORD) experience. Diabetologia 2012;55:1641-50.
  • Bonds DE, Miller ME, Dudl J, et al. Severe hypoglycemia symptoms, antecedent behaviors, immediate consequences and association with glycemia medication usage: Secondary analysis of the ACCORD clinical trial data. BMC endocrine disorders 2012;12:5.
  • Genuth S, Ismail-Beigi F. Clinical implications of the ACCORD trial. J Clin Endocrinol Metab 2012;97:41-8.
  • Gerstein HC, Ambrosius WT, Danis R, et al. Diabetic Retinopathy, its Progression and Incident Cardiovascular Events in the ACCORD Trial. Diabetes Care 2012.
  • Getaneh A, Light LS, Brillon DJ, et al. Diabetes control among Hispanics in the action to control cardiovascular risk in diabetes trial. Journal of general internal medicine 2012;27:1499-505.
  • Ismail-Beigi F, Craven TE, O’Connor PJ, et al. Combined intensive blood pressure and glycemic control does not produce an additive benefit on microvascular outcomes in type 2 diabetic patients. Kidney Int 2012;81:586-94.
  • Mychaleckyj JC, Craven T, Nayak U, et al. Reversibility of fenofibrate therapy-induced renal function impairment in ACCORD type 2 diabetic participants. Diabetes Care 2012;35:1008-14.
  • O’Connor PJ, Narayan KM, Anderson R, et al. Effect of intensive versus standard blood pressure control on depression and health-related quality of life in type 2 diabetes: the ACCORD trial. Diabetes Care 2012;35:1479-81.
  • Punthakee Z, Miller ME, Launer LJ, et al. Poor cognitive function and risk of severe hypoglycemia in type 2 diabetes: post hoc epidemiologic analysis of the ACCORD trial. Diabetes Care 2012;35:787-93.
  • Raisch DW, Feeney P, Goff DC, Jr., et al. Baseline comparison of three health utility measures and the feeling thermometer among participants in the Action to Control Cardiovascular Risk in Diabetes trial. Cardiovasc Diabetol 2012;11:35.
  • Samaropoulos XF, Light L, Ambrosius WT, Marcovina SM, Probstfield J, Jr DC. The effect of intensive risk factor management in type 2 diabetes on inflammatory biomarkers. Diabetes research and clinical practice 2012;95:389-98.
  • Schwartz AV, Margolis KL, Sellmeyer DE, et al. Intensive glycemic control is not associated with fractures or falls in the ACCORD randomized trial. Diabetes Care 2012;35:1525-31.
  • Seaquist ER, Miller ME, Bonds DE, et al. The impact of frequent and unrecognized hypoglycemia on mortality in the ACCORD study. Diabetes Care 2012;35:409-14.
  • Stiles MC, Seaquist ER, Yale JF, et al. Is silent myocardial infarction more common in women with type 2 diabetes than in men? J Diabetes Complications 2012;26:118-22.
  • Sullivan M, Evans G, Anderson R, O’Connor P, Raisch D, Simmons DL, Narayan V. Symptoms and Distress in ACCORD Trial Participants: Relationship to Baseline Clinical Variables. Clinical Diabetes 2012;30:101-8.
  • Sullivan MD, O’Connor P, Feeney P, et al. Depression predicts all-cause mortality: epidemiological evaluation from the ACCORD HRQL substudy. Diabetes Care 2012;35:1708-15.
  • Barzilay JI, Lovato JF, Murray AM, et al. Albuminuria and cognitive decline in people with diabetes and normal renal function. Clin J Am Soc Nephrol 2013;8:1907-14.
  • Gangaputra S, Lovato JF, Hubbard L, et al. Comparison of standardized clinical classification with fundus photograph grading for the assessment of diabetic retinopathy and diabetic macular edema severity. Retina 2013;33:1393-9.
  • Kirk JK, Craven T, Lipkin EW, et al. Longitudinal changes in dietary fat intake and associated changes in cardiovascular risk factors in adults with type 2 diabetes: the ACCORD trial. Diabetes research and clinical practice 2013;100:61-8.
  • Miller ME, Williamson JD, Gerstein HC, et al. Effects of Randomization to Intensive Glucose Control on Adverse Events, Cardiovascular Disease and Mortality in Older Versus Younger Adults in the ACCORD Trial. Diabetes Care 2013.
  • Reyes-Soffer G, Ngai CI, Lovato L, et al. Effect of combination therapy with fenofibrate and simvastatin on postprandial lipemia in the ACCORD lipid trial. Diabetes Care 2013;36:422-8.
  • Sullivan MD, Katon WJ, Lovato LC, et al. Association of depression with accelerated cognitive decline among patients with type 2 diabetes in the ACCORD-MIND trial. JAMA psychiatry 2013;70:1041-7.
  • Bryan RN, Bilello M, Davatzikos C, et al. Effect of diabetes on brain structure: the action to control cardiovascular risk in diabetes MR imaging baseline data. Radiology 2014;272:210-6.
  • Casanova R, Saldana S, Chew EY, Danis RP, Greven CM, Ambrosius WT. Application of random forests methods to diabetic retinopathy classification analyses. PLoS One 2014;9:e98587.
  • Chew EY, Davis MD, Danis RP, et al. The Effects of Medical Management on the Progression of Diabetic Retinopathy in Persons with Type 2 Diabetes: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study. Ophthalmology 2014;121:2443-51.
  • Fatemi O, Yuriditsky E, Tsioufis C, et al. Impact of Intensive Glycemic Control on the Incidence of Atrial Fibrillation and Associated Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus (from the Action to Control Cardiovascular Risk in Diabetes Study). Am J Cardiol 2014;114:1217-22.
  • Hugenschmidt CE, Lovato JF, Ambrosius WT, et al. The Cross-sectional and Longitudinal Associations of Diabetic Retinopathy With Cognitive Function and Brain MRI Findings: The Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial. Diabetes Care 2014;37:3244-52.
  • Isakova T, Craven TE, Lee J, et al. Fibroblast Growth Factor 23 and Incident CKD in Type 2 Diabetes. Clin J Am Soc Nephrol 2014.
  • Linz PE, Lovato LC, Byington RP, et al. Paradoxical reduction in HDL-C with fenofibrate and thiazolidinedione therapy in type 2 diabetes: the ACCORD Lipid Trial. Diabetes Care 2014;37:686-93.
  • Margolis KL, O’Connor PJ, Morgan TM, et al. Outcomes of Combined Cardiovascular Risk Factor Management Strategies in Type 2 Diabetes: The ACCORD Randomized Trial. Diabetes Care 2014;37:1721-8.
  • Margolis KL, Palermo L, Vittinghoff E, et al. Intensive Blood Pressure Control, Falls, and Fractures in Patients with Type 2 Diabetes: The ACCORD Trial. Journal of general internal medicine 2014;29:1599-606.
  • Mottl AK, Pajewski N, Fonseca V, et al. The degree of retinopathy is equally predictive for renal and macrovascular outcomes in the ACCORD Trial. J Diabetes Complications 2014;28:874-9.
  • Punthakee Z, Miller ME, Simmons DL, et al. Durable change in glycaemic control following intensive management of type 2 diabetes in the ACCORD clinical trial. Diabetologia 2014;57:2030-7.
  • Simons-Morton DG, Chan JC, Kimel AR, et al. Characteristics associated with informed consent for genetic studies in the ACCORD trial. Contemporary clinical trials 2014;37:155-64.
  • Tsioufis C, Tatsis I, Thomopoulos C, et al. Effects of hypertension, diabetes mellitus, obesity and other factors on kidney haemodynamics. Current vascular pharmacology 2014;12:537-48.
  • Williamson JD, Launer LJ, Bryan RN, et al. Cognitive function and brain structure in persons with type 2 diabetes mellitus after intensive lowering of blood pressure and lipid levels: a randomized clinical trial. JAMA internal medicine 2014;174:324-33.
  • Zhang Z, Lovato J, Battapady H, et al. Effect of Hypoglycemia on Brain Structure in People With Type 2 Diabetes: Epidemiological Analysis of the ACCORD-MIND MRI Trial. Diabetes Care 2014;37:3279-85.
  • Erus G, Battapady H, Zhang T, et al. Spatial patterns of structural brain changes in type 2 diabetic patients and their longitudinal progression with intensive control of blood glucose. Diabetes Care 2015;38:97-104.
  • Hempe JM, Liu S, Myers L, McCarter RJ, Buse JB, Fonseca V. The Hemoglobin Glycation Index Identifies Subpopulations With Harms or Benefits From Intensive Treatment in the ACCORD Trial. Diabetes Care 2015;38:1067-74.
  • Papademetriou V, Lovato L, Doumas M, et al. Chronic kidney disease and intensive glycemic control increase cardiovascular risk in patients with type 2 diabetes. Kidney Int 2015;87:649-59.
  • Siraj ES, Rubin DJ, Riddle MC, et al. Insulin Dose and Cardiovascular Mortality in the ACCORD Trial. Diabetes Care 2015;38:2000-8.
  • Group AS. Nine-Year Effects of 3.7 Years of Intensive Glycemic Control on Cardiovascular Outcomes. Diabetes Care 2016;39:701-8.
  • Shah HS, Gao H, Morieri ML, et al. Genetic Predictors of Cardiovascular Mortality During Intensive Glycemic Control in Type 2 Diabetes: Findings From the ACCORD Clinical Trial. Diabetes Care 2016.
  • Shah HS, Morieri ML, Marcovina SM, et al. Modulation of GLP-1 Levels by a Genetic Variant That Regulates the Cardiovascular Effects of Intensive Glycemic Control in ACCORD. Diabetes Care 2018;41:348-55.