Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
75 participants
INTERVENTIONAL
2024-11-08
2026-03-31
Brief Summary
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What is the effect of exercise training of high vs. moderate intensity on brain metabolism, brain perfusion, and cognition in type 2 diabetes?
Researchers will compare the exercise training groups to a control group without exercise training to determine the effect of exercise training on the brain in type 2 diabetes.
Participants will exercise for 6 months, 3 times per week. Before and after these 6 months, they will undergo:
* a brain MRI scan
* cognitive tests
* blood sampling
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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High intensity exercise training group
This arm will receive 6 months of exercise training at high intensity (105% VT2)
Exercise intervention
The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
Moderate intensity exercise training group
This arm will receive 6 months of exercise training at moderate intensity (60% VT2)
Exercise intervention
The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
Control group
This arm won't receive exercise training
No interventions assigned to this group
Interventions
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Exercise intervention
The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
Eligibility Criteria
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Inclusion Criteria
* no insulin therapy
* 30-75 years old
* right handed
* physically inactive
Exclusion Criteria
* MRI contraindications
* psychological disorders
* exogenous insulin therapy
* history of coma, transient ischemic attack, head trauma, brain tumor, stroke, epilepsy, and other central nervous system diseases that could cause dementia or presence of dementia before T2DM
* suffering from any disease with significant impact on exercise intervention participation such as: chronic heart disease (e.g. valve insufficiency ≥ grade 2) or significant arrhythmias, cardiac events less than one year ago (myocardial infarction, coronary artery bypass graft, percutaneous coronary intervention), clinical heart failure (oedema, shortness of breath), percutaneous coronary intervention less than one year ago, chronic obstructive pulmonary disease (COPD), cerebrovascular or peripheral vascular disease
* severe hypertension (\>160/110 mmHg)
* ongoing cancer, severe neuropathy (limiting exercise participation)
* renal disease (GRF \<45 ml/min/1,73 m2)
* inability to regularly participate in the exercise intervention
* pregnancy
* breastfeeding
30 Years
75 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Jessa Hospital
OTHER
Research Foundation Flanders
OTHER
Hasselt University
OTHER
Responsible Party
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Dominique Hansen
Full professor
Principal Investigators
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Dominique Hansen, Full professor
Role: PRINCIPAL_INVESTIGATOR
Hasselt University
Koen Cuypers, Assistant professor
Role: PRINCIPAL_INVESTIGATOR
Hasselt University
Locations
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Hasselt University
Hasselt, Limburg, Belgium
Countries
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Other Identifiers
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1129225N
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
BOF24KP05
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
B1152024000012
Identifier Type: -
Identifier Source: org_study_id