Impaired Glucose TolerancePhase 4NCT01219231
Effects of Physical Activity on the Brain in Impaired Glucose Tolerance (IGT)
A Phase 4 study testing Exercise in people with Impaired Glucose Tolerance, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The researchers will investigate whether exercise could provide positive effects on general brain functions in elderly people with impaired glucose tolerance. Read more about this study
- Who is it for?
- Ages 50 to 65 years
- Conditions the study is for
- Impaired Glucose Tolerance
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2010to Jan 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects with impaired glucose tolerance
- 50-65 years old
- moderate to heavy weight (BMI 25-35)
- must be able to do exercise intervention
Who cannot join
- diabetes
- younger than 50 years
- BMI < 25
- psychiatric medication
- severe disease
- MMSE < 26
- severe cardiovascular disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Neurology, Charité Universitätsmedizin
Berlin, State of Berlin
About this study
Official title: 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.
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.
- Conditions
- Impaired Glucose Tolerance
- Being tested
- Exercise
- Keywords
- Exercise, elderly, cognition, prevention, cognitive decline, Lifestyle
- Medical subject headings
- Glucose Intolerance, Motor Activity, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
6 months of aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Exercise |
| Placebo | Placebo comparator | Not described Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Auditory Verbal Learning Task
Measured: Prior to intervention and after 6 months of intervention
Secondary outcomes (2)
Functional/Structural brain changes
Measured: Prior to intervention and after 6 months of intervention
Plasma biomarkers
Measured: Prior to intervention and after 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Glucose ToleranceStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Agnes Flöel, Charite University, Berlin, Germany
- Investigators
- Agnes Flöel, MD, Prof., Principal investigator, Charité University Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219231
- Sponsor's protocol ID
- exercise_neuromod
- Status last verified
- Mar 2016
- First submitted
- 12 Oct 2010
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise in Elderly Individuals With Impaired Glucose Tolerance: Beneficial for Vasculature and Neurons?
- ClinicalTrials.gov ID
- NCT01219231
- Acronym / sponsor ID
- exercise_neuromod
- Conditions
- Impaired Glucose Tolerance
- Keywords
- Exercise, elderly, cognition, prevention, cognitive decline, Lifestyle
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- Aug 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers will investigate whether exercise could provide positive effects on general brain functions in elderly people with impaired glucose tolerance.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise |
| Placebo | Placebo comparator | Behavioral: Exercise |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- subjects with impaired glucose tolerance
- 50-65 years old
- moderate to heavy weight (BMI 25-35)
- must be able to do exercise intervention
Key exclusion criteria (7 listed)
- diabetes
- younger than 50 years
- BMI < 25
- psychiatric medication
- severe disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise6 months of aerobic exercise | Behavioural | Exercise, Placebo |
Primary outcome
Auditory Verbal Learning Task
Time frame: Prior to intervention and after 6 months of intervention
2 secondary outcomes
Functional/Structural brain changes
Time frame: Prior to intervention and after 6 months of intervention
Plasma biomarkers
Time frame: Prior to intervention and after 6 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnes Flöel, MD, Prof. principal investigator
Charité University Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exercise in people with Impaired Glucose Tolerance, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory Verbal Learning Task (time frame: Prior to intervention and after 6 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.