Back to resultsEffects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
Primary Purpose
Impaired Glucose Tolerance
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Impaired Glucose Tolerance focused on measuring Exercise, elderly, cognition, prevention, cognitive decline, Lifestyle
Eligibility Criteria
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
Sites / Locations
- Department of Neurology, Charité Universitätsmedizin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Exercise
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Auditory Verbal Learning Task
Secondary Outcome Measures
Functional/Structural brain changes
Plasma biomarkers
Full Information
NCT ID
NCT01219231
First Posted
October 12, 2010
Last Updated
March 15, 2016
Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT01219231
Brief Title
Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
Official Title
Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Glucose Tolerance
Keywords
Exercise, elderly, cognition, prevention, cognitive decline, Lifestyle
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
6 months of aerobic exercise
Primary Outcome Measure Information:
Title
Auditory Verbal Learning Task
Time Frame
Prior to intervention and after 6 months of intervention
Secondary Outcome Measure Information:
Title
Functional/Structural brain changes
Time Frame
Prior to intervention and after 6 months of intervention
Title
Plasma biomarkers
Time Frame
Prior to intervention and after 6 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Flöel, MD, Prof.
Organizational Affiliation
Charité University Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Charité Universitätsmedizin
City
Berlin
Country
Germany
12. IPD Sharing Statement
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Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
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