Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00220441
Status:
COMPLETED
Last Update Posted:
2008-07-30
First Post:
2005-09-21
Brief Title:
Cognitive Effects of Aerobic Exercise for IGT Adults
Sponsor:
Seattle Institute for Biomedical and Clinical Research
Organization:
Seattle Institute for Biomedical and Clinical Research
Study Overview
Official Title:
Cognitive Effects of Aerobic Exercise for Adults With Impaired Glucose Tolerance A Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ADA BL19 SIBCR | None | None | None |