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

Impaired Glucose Tolerance Clinical Trial

Official title:

Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01219231
• Other study ID #: exercise_neuromod
• Status: Completed
• Phase: Phase 4
• First received: October 12, 2010
• Last updated: March 15, 2016
• Start date: August 2010
• Est. completion date: January 2015

Study information

• Verified date: March 2016
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Behavioral:
• Exercise
6 months of aerobic exercise

Locations

Country	Name	City	State
Germany	Department of Neurology, Charité Universitätsmedizin	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory Verbal Learning Task		Prior to intervention and after 6 months of intervention	No
Secondary	Functional/Structural brain changes		Prior to intervention and after 6 months of intervention	No
Secondary	Plasma biomarkers		Prior to intervention and after 6 months of intervention	No