A Phase 2 interventional study of Aerobic exercise in Impaired Glucose Tolerance, sponsored by Seattle Institute for Biomedical and Clinical Research. Completed at 2 sites in United States. Open to participants aged 55 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-07-30.
Sponsored by Seattle Institute for Biomedical and Clinical Research · Phase 2, Interventional, and Treatment
The specific aims for the study will be to determine if aerobic exercise enhances cognition for older adults who are at risk for developing type II diabetes mellitus (T2DM), and to evaluate whether change in insulin sensitivity predicts cognitive performance for subjects randomized to the aerobic exercise group. Sedentary older adults diagnosed with impaired glucose tolerance using an oral glucose tolerance test will participate in a 6-month supervised protocol of either aerobic exercise or stretching. Cognitive testing and blood collection will occur at baseline, and months 3 and 6. Before and after the 6-month intervention, insulin sensitivity, maximum aerobic capacity, and body fat composition and distribution (via CT scan) will be assessed for all subjects. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that specifically targets many of the health factors that directly influence risk of cognitive decline associated with T2DM for older adults.
The benefits of exercise on cognition have been demonstrated both in animals and humans. Exercise has salutary effects on glucoregulation and visceral adiposity, an important link for adults with impaired glucose tolerance (IGT) and type 2 diabetes mellitus (T2DM). Exercise also upregulates neurotrophic activity, an effect that serves to increase neuronal viability in the same brain regions that support complex cognitive functions affected by metabolic disease. In this proposed controlled intervention trial, the hypothesis is that aerobic exercise will have a beneficial effect on cognition and several biomarkers that index disease progression for older adults with IGT. 40 older subjects (age: >55 yrs) with IGT, confirmed by OGTT, will be randomized to an aerobic fitness or stretching program for 6 months. Cognitive measures and fasting blood samples will be obtained at baseline, month 3, and month 6. Cognitive tests will evaluate abilities affected by age and by significant glucoregulatory dysregulation. In addition, all subjects will undergo a hyperinsulinemic-euglycemic clamp protocol, a cardiopulmonary fitness assessment, and body fat quantification procedures, immediately before and after the intervention. The specific aims of the study will be to determine if aerobic exercise enhances cognition for older adults with IGT, to evaluate whether exercise-induced change in insulin sensitivity predicts cognitive performance, and to relate exercise effects on insulin sensitivity and cognition to changes in specified biomarkers. The results of this study may provide support for a relatively simple and inexpensive treatment strategy that targets many of the health factors that influence risk of cognitive decline.
778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.
This study's enrollment of 40 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Seattle Institute for Biomedical and Clinical Research is the lead sponsor of 48 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Change in cognitive scores
Change in insulin sensitivity
Change in biomarkers assayed from blood
Correlation between cognitive scores, insulin sensitivity, biomarkers
This study is completed, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.
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Seattle Institute for Biomedical and Clinical Research