Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01219231
First received: October 12, 2010
Last updated: January 19, 2015
Last verified: January 2015

October 12, 2010
January 19, 2015
August 2010
January 2015   (final data collection date for primary outcome measure)
Auditory Verbal Learning Task [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01219231 on ClinicalTrials.gov Archive Site
  • Functional/Structural brain changes [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]
  • Plasma biomarkers [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Impaired Glucose Tolerance
Behavioral: Exercise
6 months of aerobic exercise
  • Experimental: Exercise
    Intervention: Behavioral: Exercise
  • Placebo Comparator: Placebo
    Intervention: Behavioral: Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
50 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01219231
exercise_neuromod
Yes
Agnes Flöel, Charite University, Berlin, Germany
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Principal Investigator: Agnes Flöel, MD, Prof. Charité University Berlin
Charite University, Berlin, Germany
January 2015

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