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Sponsors and Collaborators: |
National Institute on Aging (NIA) National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00182910 |
The purpose of this study is to test whether the rate of cognitive decline and structural brain change in people with diabetes treated with standard care guidelines is different than in people with diabetes treated with intensive care guidelines.
Condition | Intervention | Phase |
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Atherosclerosis Cardiovascular Diseases Hypercholesterolemia Hypertension Diabetes Mellitus Coronary Disease |
Drug: hypoglycemic agents Drug: hydroxymethylglutaryl-CoA Reductase inhibitors Drug: antihypertensive agents Drug: fibrates |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
Official Title: | Action to Control Cardiovascular Risk in Diabetes--Memory in Diabetes |
Enrollment: | 2977 |
Study Start Date: | October 2003 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1.: Active Comparator
Standard diabetes treatment--HbA1c Target 7.0-7.9%
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Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
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2.: Experimental
Intensive diabetes treatment--HbA1c Target 6.0%
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Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
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3.: Active Comparator
Standard lipid treatment--a statin for treatment of LDL-C
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Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
Drug: hydroxymethylglutaryl-CoA Reductase inhibitors
a statin for treatment of LDL-C
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4.: Experimental
Intensive lipid treatment--a fibrate to raise HDL-C/lower triglyceride levels plus a statin for treatment of LDL-C
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Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
Drug: hydroxymethylglutaryl-CoA Reductase inhibitors
a statin for treatment of LDL-C
Drug: fibrates
to increase HDL with fibrates
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5.: Active Comparator
Standard blood pressure treatment--target systolic blood pressure (SBP) of < 140 mm Hg
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Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
Drug: antihypertensive agents
diuretics, beta-blockers, calcium channel blockers, or ACE inhibitors
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6.: Experimental
Intensive blood pressure treatment--target systolic blood pressure (SBP) of < 120 mm Hg
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Drug: hypoglycemic agents
any hypoglycemic agent may be used, alone or in combination
Drug: antihypertensive agents
diuretics, beta-blockers, calcium channel blockers, or ACE inhibitors
|
Type 2 diabetes and cognitive impairment are two of the most common chronic conditions found in persons 60 years and older. Approximately 18%-20% of older persons suffer from diabetes. And, in the general population, the prevalence of cognitive impairment, measured with the simple Mini-Mental State Exam, increases steadily from 5% at 65 years to 15% percent at 80 years of age. Many persons with cognitive impairment go on to develop dementia, which doubles in incidence and prevalence every additional 5 years of age. Studies suggest diabetes is one risk factor for cognitive impairment and dementia.
Further, the brains of people with diabetes are at risk for complications following repeated hypoglycemic events. Magnetic Resonance Imaging (MRI) provides a measure of the structural changes in the brain that form the anatomical substrate for cognitive decline and dementia. At present there are a few MRI studies showing people with diabetes have increased risk for brain atrophy and (mainly silent) lacunae.
The comparison of standard diabetes care with intensive diabetes care will be made in a sub-sample of 2800 people (including 640 for MRI) with diabetes currently participating in the ongoing National Heart Lung and Blood Institute (NHLBI) Action to Control Cardiovascular Risk in Diabetes (ACCORD). ACCORD is designed to evaluate whether more intensive glucose, blood pressure and lipid management can reduce cardiovascular disease in people with diabetes. Participants in ACCORD-MIND will have already been randomly assigned to either the intensive or standard diabetes care in the ACCORD trial, and will already have been randomized to either the blood pressure or lipid intervention arms (see NCT00000620). ACCORD-MIND will test these patients for cognitive function and changes in brain structure.
Tests of cognitive function measure memory and executive function, which includes speed of processing, attention, planning, and concentration. They are indicators of how well a person performs various tasks in daily life. Cognitive impairment is also predictive of future onset of dementia. In diabetes, cognitive impairment may compromise an individual's ability to manage his/her disease, an important factor that should be incorporated into an analysis of the trial efficacy.
MRI is a safe, non-invasive method to assess the structural characteristics of the brain. With MRI, investigators may begin to identify vascular lesions and brain atrophy that form the anatomical basis for cognitive changes that may be associated with the ACCORD treatments.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
National Institute on Aging | |
Bethesda, Maryland, United States, 20892 | |
United States, Minnesota | |
Minnesota-Iowa Network, Hennepin County Medical Center | |
Minneapolis, Minnesota, United States | |
United States, New York | |
Northeast Network, Columbia University | |
New York, New York, United States | |
United States, North Carolina | |
Southeast Network, Wake Forest University | |
Winston-Salem, North Carolina, United States | |
United States, Ohio | |
Ohio-Michigan Network, University Hospitals of Cleveland | |
Cleveland, Ohio, United States | |
United States, Washington | |
Western Network, University of Washington | |
Seattle, Washington, United States | |
Canada, Ontario | |
Canada Network, McMaster Medical Centre | |
Hamilton, Ontario, Canada |
Principal Investigator: | Lenore J. Launer, PhD | Chief, Neuroepidemiology Section, Laboratory of Epidemiology, Demography, and Biometry, National Institute on Aging, National Institutes of Health |
Responsible Party: | LEDB/IRP/NIA ( Lenore J. Launer ) |
Study ID Numbers: | IA0080 |
Study First Received: | September 9, 2005 |
Last Updated: | June 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00182910 |
Health Authority: | United States: Federal Government |
Cognitive Impairment MCI dementia Alzheimer's disease |
Atherosclerosis Arterial Occlusive Diseases Clofibric Acid Hyperlipidemias Metabolic Diseases Heart Diseases Myocardial Ischemia Alzheimer Disease Diabetes Mellitus Vascular Diseases Endocrine System Diseases Arteriosclerosis |
Ischemia Coronary Disease Calcium, Dietary Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Dementia Hypercholesterolemia Dyslipidemias Coronary Artery Disease Lipid Metabolism Disorders Hypertension |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Cardiovascular Diseases Anticholesteremic Agents Pharmacologic Actions |