Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
This study is currently recruiting participants.
Verified May 2013 by Charite University, Berlin, Germany
Sponsor:
Charite University, Berlin, Germany
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Agnes Floeel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01219231
First received: October 12, 2010
Last updated: May 3, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | March 2014 |
| Estimated Primary Completion Date: | December 2013 (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
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 Floeel, 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: | May 3, 2013 |
| 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 May 22, 2013