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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Charite University, Berlin, Germany
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: June 2, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Impaired Glucose Tolerance
Behavioral: Exercise
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Auditory Verbal Learning Task [ Time Frame: Prior to intervention and after 6 months of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 46
Study Start Date: August 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Behavioral: Exercise
6 months of aerobic exercise
Placebo Comparator: Placebo Behavioral: Exercise
6 months of aerobic exercise

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.

  Eligibility

Ages Eligible for Study:   50 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01219231

Locations
Germany
Department of Neurology, Charité Universitätsmedizin Recruiting
Berlin, Germany
Contact: Agnes Floeel, Prof.       agnes.floeel@charite.de   
Contact: Veronica Witte, PhD       veronica.witte@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Agnes Flöel, MD, Prof. Charité University Berlin
  More Information

No publications provided

Responsible Party: Agnes Flöel, Prof, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01219231     History of Changes
Other Study ID Numbers: exercise_neuromod
Study First Received: October 12, 2010
Last Updated: June 2, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
Exercise
elderly
cognition
prevention
cognitive decline
Lifestyle

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

ClinicalTrials.gov processed this record on September 16, 2014