Cognitive Effects of Aerobic Exercise for IGT Adults

July 29, 2008 updated by: Seattle Institute for Biomedical and Clinical Research

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in cognitive scores
Change in insulin sensitivity

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seattle Institute for Biomedical and Clinical Research

Collaborators

American Diabetes Association

Investigators

  • Principal Investigator: Laura D. Baker, PhD, VA Puget Sound Health Care System; University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 21, 2005

First Submitted That Met QC Criteria

September 21, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

July 30, 2008

Last Update Submitted That Met QC Criteria

July 29, 2008

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDIS 0009
  • ADA BL19 (SIBCR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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