Cognitive Effects of Aerobic Exercise for IGT Adults - Full Text View

Sponsors and Collaborators:	Seattle Institute for Biomedical and Clinical Research American Diabetes Association
Information provided by:	Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:	NCT00220441

Purpose

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.

Condition	Intervention	Phase
Impaired Glucose Tolerance	Behavioral: Aerobic exercise	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Cognitive Effects of Aerobic Exercise for Adults With Impaired Glucose Tolerance: A Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Seattle Institute for Biomedical and Clinical Research:

Primary Outcome Measures:

Change in cognitive scores
Change in insulin sensitivity

Secondary Outcome Measures:

Change in biomarkers assayed from blood
Correlation between cognitive scores, insulin sensitivity, biomarkers

Estimated Enrollment:	40
Study Start Date:	July 2004
Study Completion Date:	April 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

diagnosed with IGT using OGTT, at least 55 years old, sedentary (elevated HR & SOB < 3x/wk for <30min each occasion), good overall health, willing to exercise at least 4 days/week for 6 mos

Exclusion Criteria:

Significant neurologic disease that might affect cognition, such as AD, stroke, Parkinson's disease, multiple sclerosis, or severe head injury with loss of consciousness; significant medical illness or organ failure, such as liver disease, significant elevations in liver function tests, kidney disease, and uncontrolled hypertension (BP > 140/90 on medication); cardiovascular disease defined as any acute cardiovascular abnormality, such as new or unstable angina, uncontrolled irregular heart beat (treated a-fib and occasional PVC's are OK) or symptomatic heart failure, acute shortness of breath for any reason, or clinically significant edema; chronic lung disease, (COPD/emphysema); musculoskeletal impairment (impaired walking); current use of anti-psychotic, anti-convulsant, anti-coagulant, sedative medication, or cognition-enhancing medications; current or previous use of hypoglycemic agents or insulin.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00220441

Locations

United States, Washington
Veterans Affairs Puget Sound Health Care System
Tacoma, Washington, United States, 98493
Veterans Affairs Puget Sound Health Care System
Seattle, Washington, United States, 98108

Sponsors and Collaborators

Seattle Institute for Biomedical and Clinical Research

American Diabetes Association

Investigators

Principal Investigator:

Laura D. Baker, PhD

VA Puget Sound Health Care System; University of Washington

More Information

No publications provided

Study ID Numbers:	RDIS 0009, ADA BL19 (SIBCR)
Study First Received:	September 21, 2005
Last Updated:	July 29, 2008
ClinicalTrials.gov Identifier:	NCT00220441 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Seattle Institute for Biomedical and Clinical Research:

IGT
exercise
cognition

insulin
aging
aerobic

Study placed in the following topic categories:

Metabolic Diseases
Hyperglycemia
Glucose Intolerance

Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Metabolic Diseases
Hyperglycemia
Glucose Intolerance
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 11, 2009