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Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)

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ClinicalTrials.gov Identifier: NCT01219231
Recruitment Status : Completed
First Posted : October 13, 2010
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The researchers will investigate whether exercise could provide positive effects on general brain functions in elderly people with impaired glucose tolerance.

Condition or disease Intervention/treatment Phase
Impaired Glucose Tolerance Behavioral: Exercise Phase 4

Detailed Description:

The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as Alzheimer`s disease are a growing public-health concern with devastating effects.

Referring to animal data, empirical studies, and pilot human trials, exercise should improve cognitive functions such as learning and memory. To test this hypothesis, the researchers study general brain functions in elderly subjects (50-80 years old) with impaired glucose tolerance during a short term exercise program.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?
Study Start Date : August 2010
Primary Completion Date : January 2015
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Exercise Behavioral: Exercise
6 months of aerobic exercise
Placebo Comparator: Placebo Behavioral: Exercise
6 months of aerobic exercise

Outcome Measures

Primary Outcome Measures :
  1. Auditory Verbal Learning Task [ Time Frame: Prior to intervention and after 6 months of intervention ]

Secondary Outcome Measures :
  1. Functional/Structural brain changes [ Time Frame: Prior to intervention and after 6 months of intervention ]
  2. Plasma biomarkers [ Time Frame: Prior to intervention and after 6 months of intervention ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • subjects with impaired glucose tolerance
  • 50-65 years old
  • moderate to heavy weight (BMI 25-35)
  • must be able to do exercise intervention

Exclusion Criteria:

  • diabetes
  • younger than 50 years
  • BMI < 25
  • psychiatric medication
  • severe disease
  • MMSE < 26
  • severe cardiovascular disorders
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01219231

Department of Neurology, Charité Universitätsmedizin
Berlin, Germany
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Principal Investigator: Agnes Flöel, MD, Prof. Charité University Berlin
More Information

Responsible Party: Agnes Flöel, Prof, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01219231     History of Changes
Other Study ID Numbers: exercise_neuromod
First Posted: October 13, 2010    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
cognitive decline

Additional relevant MeSH terms:
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases