Clinical Trials Directory

Trials / Completed

CompletedNCT00220441

Cognitive Effects of Aerobic Exercise for IGT Adults

Cognitive Effects of Aerobic Exercise for Adults With Impaired Glucose Tolerance: A Controlled Trial

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
40 (planned)
Sponsor
Seattle Institute for Biomedical and Clinical Research · Academic / Other
Sex
All
Age
55 Years – 90 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALAerobic exercise

Timeline

Start date
2004-07-01
Primary completion
2007-12-01
Completion
2008-04-01
First posted
2005-09-22
Last updated
2008-07-30

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00220441. Inclusion in this directory is not an endorsement.