The Effect of Exercise on the Brain in Type 2 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Exercise intervention.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Exercise of High vs. Moderate Intensity on the Brain in Type 2 Diabetes
Overview
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
Interventions
- Other Exercise intervention
The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
Primary outcome measures
- Neurometabolite levels [Time frame: From enrollment to the end of treatment at 6 months]
- Changes in arterial spin labelling measured by means of magnetic resonance imaging (MRI) [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (12)
- Levels of neurodegenerative blood biomarkers [Time frame: From enrollment to the end of treatment at 6 months]
- Blood lipid profile [Time frame: From enrollment to the end of treatment at 6 months]
- Brain volume [Time frame: From enrollment to the end of treatment at 6 months]
- Diffusion-weighted magnetic resonance imaging [Time frame: From enrollment to the end of treatment at 6 months]
- Fasted blood glucose [Time frame: From enrollment to the end of treatment at 6 months]
- Kidney function (eGFR) [Time frame: From enrollment to the end of treatment at 6 months]
- Cognitive function: MoCA [Time frame: From enrollment to the end of treatment at 6 months]
- Cognitive function: Face recognition test [Time frame: From enrollment to the end of treatment at 6 months]
- Cognitive function: Object location test [Time frame: From enrollment to the end of treatment at 6 months]
- Cognitive function: Trail making test [Time frame: From enrollment to the end of treatment at 6 months]
- Cognitive function: Stroop colour and word test [Time frame: From enrollment to the end of treatment at 6 months]
- Cognitive function: Rey auditory verbal learning test [Time frame: From enrollment to the end of treatment at 6 months]
Eligibility criteria
Inclusion criteria
- type 2 diabetes
- no insulin therapy
- 30-75 years old
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Belgium · 1 center
- Hasselt University — Hasselt
Identifiers
NCT: NCT06734546 · B1152024000012 · 1129225N · BOF24KP05