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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
75
The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
Hasselt University
Hasselt, Limburg, Belgium
RECRUITINGNeurometabolite 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).
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)
Changes in cerebral perfusion expressed in mL/100g/min, and blood flow through the blood-brain-barrier expressed in milliseconds
Time frame: From enrollment to the end of treatment at 6 months
Levels of neurodegenerative blood biomarkers
Tau (pg/mL), amyloid beta (pg/mL), S100B (ng/mL), neurofilament light (pg/mL) etc.
Time frame: From enrollment to the end of treatment at 6 months
Blood lipid profile
This outcome measure includes assessments of the lipid profile, reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L): High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), Triglycerides, Free Fatty Acids, Total Cholesterol
Time frame: From enrollment to the end of treatment at 6 months
Brain volume
Total and regional (LHIPP, mPFC, PCC) brain volumes
Time frame: From enrollment to the end of treatment at 6 months
Diffusion-weighted magnetic resonance imaging
DWI will be used to measure differences in Brownian motion of water molecules within the brain
Time frame: From enrollment to the end of treatment at 6 months
Fasted blood glucose
Fasting Glucose: Reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L).
Time frame: From enrollment to the end of treatment at 6 months
Kidney function (eGFR)
Estimated Glomerular Filtration Rate (eGFR): Reported in milliliters per minute per 1.73 m² (mL/min/1.73 m²).
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: MoCA
Cognitive function as assessed by the Montreal Cognitive Assessment (MoCA), scored on a scale of 0-30.
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Face recognition test
Cognitive function as assessed by the Face Recognition Test, reported as the number of correct identifications.
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Object location test
Cognitive function as assessed by the Object Location Test, reported as the number of correct placements.
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Trail making test
Cognitive function as assessed by the Trail Making Test, reported as time to completion (seconds) for Parts A and B.
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Stroop colour and word test
Cognitive function as assessed by the Stroop Color and Word Test, reported as time to completion (seconds) or number of errors.
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Rey auditory verbal learning test
Cognitive function as assessed by the Rey Auditory Verbal Learning Test, reported as the number of words recalled.
Time frame: From enrollment to the end of treatment at 6 months
Subjective cognitive function
Cognitive function as assessed by the Cognitive Failure Questionnaire, scored on a scale of 0-100.
Time frame: From enrollment to the end of treatment at 6 months
Peak load during CPET
The maximum load achieved during cardiopulmonary exercise testing (CPET) on a bicycle, measured in watts.
Time frame: From enrollment to the end of treatment at 6 months
VO2peak during CPET
The peak oxygen consumption measured during CPET, indicating the maximal capacity for oxygen utilization during exercise. Unit of Measure: Milliliters per kilogram per minute (mL/kg/min).
Time frame: From enrollment to the end of treatment at 6 months
Fasted blood HbA1c
Hemoglobin A1c (HbA1c): Reported as a percentage (%).
Time frame: From enrollment to the end of treatment at 6 months
Fasting insulin
Fasting Insulin: Reported in micro-international units per milliliter (μIU/mL) or picomoles per liter (pmol/L).
Time frame: From enrollment to the end of treatment at 6 months
Kidney function (creatinine)
Creatinine: Reported in milligrams per deciliter (mg/dL) or micromoles per liter (μmol/L).
Time frame: From enrollment to the end of treatment at 6 months
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