PMID- 24493100 OWN - NLM STAT- MEDLINE DCOM- 20140501 LR - 20220408 IS - 2168-6114 (Electronic) IS - 2168-6106 (Print) IS - 2168-6106 (Linking) VI - 174 IP - 3 DP - 2014 Mar TI - 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. PG - 324-33 LID - 10.1001/jamainternmed.2013.13656 [doi] AB - IMPORTANCE: Persons with type 2 diabetes mellitus (T2DM) are at increased risk for decline in cognitive function, reduced brain volume, and increased white matter lesions in the brain. Poor control of blood pressure (BP) and lipid levels are risk factors for T2DM-related cognitive decline, but the effect of intensive treatment on brain function and structure is unknown. OBJECTIVE: To examine whether intensive therapy for hypertension and combination therapy with a statin plus a fibrate reduces the risk of decline in cognitive function and total brain volume (TBV) in patients with T2DM. DESIGN, SETTING, AND PARTICIPANTS: A North American multicenter clinical trial including 2977 participants without baseline clinical evidence of cognitive impairment or dementia and with hemoglobin A1c (HbA1c) levels less than 7.5% randomized to a systolic BP goal of less than 120 vs less than 140 mm Hg (n = 1439) or to a fibrate vs placebo in patients with low-density lipoprotein cholesterol levels less than 100 mg/dL (n = 1538). Participants were recruited from August 1, 2003, through October 31, 2005, with the final follow-up visit by June 30, 2009. MAIN OUTCOME MEASURES: Cognition was assessed at baseline and 20 and 40 months. A subset of 503 participants underwent baseline and 40-month brain magnetic resonance imaging to assess for change in TBV and other structural measures of brain health. RESULTS: Baseline mean HbA1c level was 8.3%; mean age, 62 years; and mean duration of T2DM, 10 years. At 40 months, no differences in cognitive function were found in the intensive BP-lowering trial or in the fibrate trial. At 40 months, TBV had declined more in the intensive vs standard BP-lowering group (difference, -4.4 [95% CI, -7.8 to -1.1] cm(3); P = .01). Fibrate therapy had no effect on TBV compared with placebo. CONCLUSIONS AND RELEVANCE: In participants with long-standing T2DM and at high risk for cardiovascular events, intensive BP control and fibrate therapy in the presence of controlled low-density lipoprotein cholesterol levels did not produce a measurable effect on cognitive decline at 40 months of follow-up. Intensive BP control was associated with greater decline in TBV at 40 months relative to standard therapy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00000620. FAU - Williamson, Jeff D AU - Williamson JD AD - Roena B. Kulynych Center for Memory and Cognition Research, Department of Internal Medicine, Wake Forest University, Winston-Salem, North Carolina. FAU - Launer, Lenore J AU - Launer LJ AD - Intramural Research Program, National Institute on Aging, National Institutes of Health, Bethesda, Maryland. FAU - Bryan, R Nick AU - Bryan RN AD - Department of Radiology, University of Pennsylvania Health System, Philadelphia. FAU - Coker, Laura H AU - Coker LH AD - Division of Public Health Sciences, Department of Social Sciences and Health Policy, Wake Forest University, Winston-Salem, North Carolina. FAU - Lazar, Ronald M AU - Lazar RM AD - Departments of Neurology and Neurological Surgery, Columbia University College of Physicians and Surgeons, New York, New York. FAU - Gerstein, Hertzel C AU - Gerstein HC AD - Department of Medicine, McMaster University, Hamilton, Ontario, Canada7Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada. FAU - Murray, Anne M AU - Murray AM AD - Hennepin County Medical Center and Chronic Disease Research Group, Minneapolis, Minnesota. FAU - Sullivan, Mark D AU - Sullivan MD AD - Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle. FAU - Horowitz, Karen R AU - Horowitz KR AD - Department of Medicine, Case Western Reserve University School of Medicine, Cleveland, Ohio. FAU - Ding, Jingzhong AU - Ding J AD - Roena B. Kulynych Center for Memory and Cognition Research, Department of Internal Medicine, Wake Forest University, Winston-Salem, North Carolina. FAU - Marcovina, Santica AU - Marcovina S AD - Northwest Lipid Metabolism and Diabetes Research Laboratories, University of Washington, Seattle. FAU - Lovato, Laura AU - Lovato L AD - Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina. FAU - Lovato, James AU - Lovato J AD - Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina. FAU - Margolis, Karen L AU - Margolis KL AD - Division of Epidemiology and Community Health, University of Minnesota Medical School, Minneapolis. FAU - Davatzikos, Christos AU - Davatzikos C AD - Department of Radiology, University of Pennsylvania Health System, Philadelphia. FAU - Barzilay, Joshua AU - Barzilay J AD - Kaiser Permanente, Crescent Center Medical Office, Tucker, Georgia. FAU - Ginsberg, Henry N AU - Ginsberg HN AD - Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York. FAU - Linz, Peter E AU - Linz PE AD - Cardiology Division, Naval Medical Center San Diego, San Diego, California. FAU - Miller, Michael E AU - Miller ME AD - Department of Biostatistical Sciences, Division of Public Health Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina. CN - Action to Control Cardiovascular Risk in Diabetes Memory in Diabetes Investigators LA - eng SI - ClinicalTrials.gov/NCT00000620 GR - HHSN268201100027C/HL/NHLBI NIH HHS/United States GR - U54 GM104940/GM/NIGMS NIH HHS/United States PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural PL - United States TA - JAMA Intern Med JT - JAMA internal medicine JID - 101589534 RN - 0 (Antihypertensive Agents) RN - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors) RN - 0 (Lipids) SB - IM CIN - JAMA Intern Med. 2014 Mar;174(3):333-5. PMID: 24492927 CIN - BMJ. 2014;348:g1302. PMID: 24495841 MH - Aged MH - Antihypertensive Agents/pharmacology/therapeutic use MH - Blood Pressure/*drug effects MH - Brain/drug effects/*pathology MH - Cognition/drug effects/*physiology MH - Diabetes Mellitus, Type 2/blood/pathology/*psychology MH - Female MH - Humans MH - Hydroxymethylglutaryl-CoA Reductase Inhibitors/pharmacology/therapeutic use MH - Hypercholesterolemia/*drug therapy MH - Hypertension/*drug therapy MH - Lipids/*blood MH - Magnetic Resonance Imaging MH - Male MH - Middle Aged MH - Risk Factors MH - Treatment Outcome PMC - PMC4423790 MID - NIHMS673871 COIS- Conflict of Interest Disclosures: No other disclosures were reported. 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DesRochers SK FIR - Swift, Reyna IR - Swift R FIR - Wysham, Carol IR - Wysham C FIR - Weeks, Debbie IR - Weeks D FIR - Kuntsmann, Linda IR - Kuntsmann L FIR - Dudl, Jim IR - Dudl J FIR - Wu, Patricia IR - Wu P FIR - Lyons, Laura IR - Lyons L FIR - Murray, Margaret IR - Murray M FIR - Palma, Anton IR - Palma A FIR - Stevenson, Rachel IR - Stevenson R FIR - Dailey, George IR - Dailey G FIR - Philas-Tsimikas, Athena IR - Philas-Tsimikas A FIR - Giannella, Anna IR - Giannella A FIR - Bravo-Medina, A IR - Bravo-Medina A FIR - Jacobson, Melissa IR - Jacobson M FIR - Farro, Estela IR - Farro E FIR - Cruz, S IR - Cruz S FIR - Juarez, Noemi IR - Juarez N FIR - Dadkhah, Connie IR - Dadkhah C EDAT- 2014/02/05 06:00 MHDA- 2014/05/03 06:00 PMCR- 2015/05/07 CRDT- 2014/02/05 06:00 PHST- 2014/02/05 06:00 [entrez] PHST- 2014/02/05 06:00 [pubmed] PHST- 2014/05/03 06:00 [medline] PHST- 2015/05/07 00:00 [pmc-release] AID - 1819574 [pii] AID - 10.1001/jamainternmed.2013.13656 [doi] PST - ppublish SO - JAMA Intern Med. 2014 Mar;174(3):324-33. doi: 10.1001/jamainternmed.2013.13656.