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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00212290 |
The purpose of this study is to examine the effects of treating insulin resistance on memory and attention, brain glucose utilization, and proteins in spinal fluid.
Condition | Intervention | Phase |
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Insulin Resistance Type 2 Diabetes Mellitus |
Drug: pioglitazone Drug: nateglinide Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 140 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | December 2006 |
Insulin resistant conditions such as impaired glucose tolerance, type 2 diabetes mellitus, and hyperinsulinemia have been associated with an increased risk for memory decline and for Alzheimer's disease. The main study will determine whether treatment with pioglitazone or nateglinide will improve verbal memory and selective attention for older adults with impaired glucose tolerance or mild type 2 diabetes. The main study will also characterize changes in blood concentrations of insulin, inflammatory markers, and the beta-amyloid peptides that are related to Alzheimer's disease. In one sub-study, participants will undergo brain positron emission tomography (PET) imaging before and after 16 weeks of treatment with pioglitazone, nateglinide, or placebo. The purpose of this sub-study is to determine the effects of treatment on brain glucose utilization. In a second sub-study, participants will undergo a lumbar puncture procedure before and after treatment. The purpose of this sub-study is to determine the effects of treatment on spinal fluid concentrations of insulin, inflammatory markers, and beta-amyloid peptides. Together these main and sub-studies should characterize the effects of insulin resistance on cognition and suggest a mechanism by which insulin resistant conditions increase risk for memory decline and for Alzheimer's disease.
Ages Eligible for Study: | 55 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Washington | |
VA Puget Sound Health Care System (Seattle Campus) | |
Seattle, Washington, United States, 98108 | |
VA Puget Sound Health Care System (American Lake Campus) | |
Tacoma, Washington, United States, 98493 |
Principal Investigator: | Suzanne Craft, PhD | VA Puget Sound Health Care System, University of Washington |
Study ID Numbers: | DK61606 |
Study First Received: | September 20, 2005 |
Last Updated: | December 13, 2007 |
ClinicalTrials.gov Identifier: | NCT00212290 |
Health Authority: | United States: Federal Government |
impaired glucose tolerance |
Metabolic Diseases Pioglitazone Glucose Intolerance Diabetes Mellitus Endocrine System Diseases Nateglinide Insulin |
Hyperinsulinism Diabetes Mellitus, Type 2 Insulin Resistance Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |