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| ID | Type | Description | Link |
|---|---|---|---|
| 1129225N | Other Grant/Funding Number | FWO (Fonds Wetenschappelijk Onderzoek) | |
| BOF24KP05 | Other Grant/Funding Number | BOF (Bijzonder Onderzoeksfonds) |
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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
| Jessa Hospital | OTHER |
| Research Foundation Flanders | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High intensity exercise training group | Experimental | This arm will receive 6 months of exercise training at high intensity (105% VT2) |
|
| Moderate intensity exercise training group | Experimental | This arm will receive 6 months of exercise training at moderate intensity (60% VT2) |
|
| Control group | No Intervention | This arm won't receive exercise training |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise intervention | Other | The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Levels of neurodegenerative blood biomarkers | Tau (pg/mL), amyloid beta (pg/mL), S100B (ng/mL), neurofilament light (pg/mL) etc. | From enrollment to the end of treatment at 6 months |
| Blood lipid profile |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique Hansen, Full Professor | Contact | +3211292126 | dominique.hansen@uhasselt.be | |
| Jitske Vandersmissen, PhD student | Contact | +3211268387 | jitske.vandersmissen@uhasselt.be |
| Name | Affiliation | Role |
|---|---|---|
| Dominique Hansen, Full professor | Hasselt University | Principal Investigator |
| Koen Cuypers, Assistant professor | Hasselt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hasselt University | Recruiting | Hasselt | Limburg | 3500 | Belgium |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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
| From enrollment to the end of treatment at 6 months |
| Brain volume | Total and regional (LHIPP, mPFC, PCC) brain volumes | 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 | 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | From enrollment to the end of treatment at 6 months |
| Fasted blood HbA1c | Hemoglobin A1c (HbA1c): Reported as a percentage (%). | 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). | 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). | From enrollment to the end of treatment at 6 months |
| D004700 | Endocrine System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |