The Effect of Exercise on the Brain in Type 2 Diabetes
SAINT
The Effect of Exercise of High vs. Moderate Intensity on the Brain in Type 2 Diabetes
3 other identifiers
interventional
75
1 country
1
Brief Summary
The goal of this clinical trial is to learn if exercise training of high or moderate intensity is most optimal to improve brain health and prevent neurodegeneration in type 2 diabetes patients. The main question it aims to answer is: 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Nov 2024
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2024
CompletedFirst Submitted
Initial submission to the registry
November 25, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
March 31, 2026
March 1, 2026
2.7 years
November 25, 2024
March 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neurometabolite levels
Levels of N-acetylaspartate, choline, myo-inositol, creatine, glutathion, and glutamate, measured in institutional units (i.u.) by means of magnetic resonance spectroscopy (MRS).
From enrollment to the end of treatment at 6 months
Changes in arterial spin labelling measured by means of magnetic resonance imaging (MRI)
Changes in cerebral perfusion expressed in mL/100g/min, and blood flow through the blood-brain-barrier expressed in milliseconds
From enrollment to the end of treatment at 6 months
Secondary Outcomes (18)
Levels of neurodegenerative blood biomarkers
From enrollment to the end of treatment at 6 months
Blood lipid profile
From enrollment to the end of treatment at 6 months
Brain volume
From enrollment to the end of treatment at 6 months
Diffusion-weighted magnetic resonance imaging
From enrollment to the end of treatment at 6 months
Fasted blood glucose
From enrollment to the end of treatment at 6 months
- +13 more secondary outcomes
Study Arms (3)
High intensity exercise training group
EXPERIMENTALThis arm will receive 6 months of exercise training at high intensity (105% VT2)
Moderate intensity exercise training group
EXPERIMENTALThis arm will receive 6 months of exercise training at moderate intensity (60% VT2)
Control group
NO INTERVENTIONThis arm won't receive exercise training
Interventions
The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
Eligibility Criteria
You may qualify if:
- type 2 diabetes
- no insulin therapy
- years old
- physically inactive
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hasselt Universitylead
- Universitaire Ziekenhuizen KU Leuvencollaborator
- Jessa Hospitalcollaborator
- Research Foundation Flanderscollaborator
Study Sites (1)
Hasselt University
Hasselt, Limburg, 3500, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dominique Hansen, Full professor
Hasselt University
- PRINCIPAL INVESTIGATOR
Koen Cuypers, Assistant professor
Hasselt University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full professor
Study Record Dates
First Submitted
November 25, 2024
First Posted
December 16, 2024
Study Start
November 8, 2024
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
March 31, 2026
Record last verified: 2026-03