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CompletedNCT01219231Updated Mar 16, 2016

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

A Phase 4 interventional study of Exercise in Impaired Glucose Tolerance, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 50 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Charite University, Berlin, Germany · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
50 Years to 65 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Impaired Glucose Tolerance

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Keywords

  • Exercise
  • elderly
  • cognition
  • prevention
  • cognitive decline
  • Lifestyle
03

In context

Glucose Intolerance

778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.

This study's planned enrollment of 46 is below the median of 60 across 645 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 65 Years
Sexes eligible
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

Exclusion Criteria:

  • diabetes
  • younger than 50 years
  • BMI \< 25
  • psychiatric medication
  • severe disease
  • MMSE \< 26
  • severe cardiovascular disorders
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (estimated)

Study arms

  • Experimental
    Exercise

    Behavioral: Exercise

  • Placebo comparator
    Placebo

    Behavioral: Exercise

Interventions

  • BehavioralExercise

    6 months of aerobic exercise

06

What researchers measure

Primary outcomes

  1. Auditory Verbal Learning Task

    Time frame: Prior to intervention and after 6 months of intervention

Secondary outcomes

  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

07

Study locations

1 site
  • Department of Neurology, Charité Universitätsmedizin
    Berlin, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01219231
Lead sponsor
Charite University, Berlin, Germany
Collaborators
German Federal Ministry of Education and Research
Responsible party
Agnes Flöel (Prof, Charite University, Berlin, Germany) — Principal investigator
First posted
Oct 13, 2010
Start date
Aug 2010
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Mar 16, 2016

Study contacts

Agnes Flöel, MD, Prof.
principal investigator · Charité University Berlin

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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