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Cognitive Effects of Aerobic Exercise for IGT Adults

This study has been completed.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by:
Seattle Institute for Biomedical and Clinical Research
ClinicalTrials.gov Identifier:
NCT00220441
First received: September 21, 2005
Last updated: July 29, 2008
Last verified: July 2008

September 21, 2005
July 29, 2008
July 2004
December 2007   (final data collection date for primary outcome measure)
  • Change in cognitive scores
  • Change in insulin sensitivity
Same as current
Complete list of historical versions of study NCT00220441 on ClinicalTrials.gov Archive Site
  • Change in biomarkers assayed from blood
  • Correlation between cognitive scores, insulin sensitivity, biomarkers
Same as current
Not Provided
Not Provided
 
Cognitive Effects of Aerobic Exercise for IGT Adults
Cognitive Effects of Aerobic Exercise for Adults With Impaired Glucose Tolerance: A Controlled Trial

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Impaired Glucose Tolerance
Behavioral: Aerobic exercise
Not Provided
Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Cholerton BA, Plymate SR, Fishel MA, Watson GS, Duncan GE, Mehta PD, Craft S. Aerobic exercise improves cognition for older adults with glucose intolerance, a risk factor for Alzheimer's disease. J Alzheimers Dis. 2010;22(2):569-79.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
April 2008
December 2007   (final data collection date for primary outcome measure)

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.
Both
55 Years to 90 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00220441
RDIS 0009, ADA BL19 (SIBCR)
No
Not Provided
Seattle Institute for Biomedical and Clinical Research
American Diabetes Association
Principal Investigator: Laura D. Baker, PhD VA Puget Sound Health Care System; University of Washington
Seattle Institute for Biomedical and Clinical Research
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP