Type 2 Diabetes
Conditions
Keywords
type 2 diabetes, exercise intervention, brain, cognition, neurometabolism, dementia, cerebral perfusion
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
Interventions
OTHERExercise intervention
The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
Sponsors
Hasselt University
Universitaire Ziekenhuizen KU Leuven
Jessa Hospital
Research Foundation Flanders
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurometabolite levels | From enrollment to the end of treatment at 6 months | Levels of N-acetylaspartate, choline, myo-inositol, creatine, glutathion, and glutamate, measured in institutional units (i.u.) by means of magnetic resonance spectroscopy (MRS). |
| Changes in arterial spin labelling measured by means of magnetic resonance imaging (MRI) | From enrollment to the end of treatment at 6 months | Changes in cerebral perfusion expressed in mL/100g/min, and blood flow through the blood-brain-barrier expressed in milliseconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of neurodegenerative blood biomarkers | From enrollment to the end of treatment at 6 months | Tau (pg/mL), amyloid beta (pg/mL), S100B (ng/mL), neurofilament light (pg/mL) etc. |
| Blood lipid profile | From enrollment to the end of treatment at 6 months | 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 |
| Brain volume | From enrollment to the end of treatment at 6 months | Total and regional (LHIPP, mPFC, PCC) brain volumes |
| Diffusion-weighted magnetic resonance imaging | From enrollment to the end of treatment at 6 months | DWI will be used to measure differences in Brownian motion of water molecules within the brain |
| Fasted blood glucose | From enrollment to the end of treatment at 6 months | Fasting Glucose: Reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L). |
| Kidney function (eGFR) | From enrollment to the end of treatment at 6 months | Estimated Glomerular Filtration Rate (eGFR): Reported in milliliters per minute per 1.73 m² (mL/min/1.73 m²). |
| Cognitive function: MoCA | From enrollment to the end of treatment at 6 months | Cognitive function as assessed by the Montreal Cognitive Assessment (MoCA), scored on a scale of 0-30. |
| Cognitive function: Face recognition test | From enrollment to the end of treatment at 6 months | Cognitive function as assessed by the Face Recognition Test, reported as the number of correct identifications. |
| Cognitive function: Object location test | From enrollment to the end of treatment at 6 months | Cognitive function as assessed by the Object Location Test, reported as the number of correct placements. |
| Cognitive function: Trail making test | From enrollment to the end of treatment at 6 months | Cognitive function as assessed by the Trail Making Test, reported as time to completion (seconds) for Parts A and B. |
| Cognitive function: Stroop colour and word test | From enrollment to the end of treatment at 6 months | Cognitive function as assessed by the Stroop Color and Word Test, reported as time to completion (seconds) or number of errors. |
| Cognitive function: Rey auditory verbal learning test | From enrollment to the end of treatment at 6 months | Cognitive function as assessed by the Rey Auditory Verbal Learning Test, reported as the number of words recalled. |
| Subjective cognitive function | From enrollment to the end of treatment at 6 months | Cognitive function as assessed by the Cognitive Failure Questionnaire, scored on a scale of 0-100. |
| Peak load during CPET | From enrollment to the end of treatment at 6 months | The maximum load achieved during cardiopulmonary exercise testing (CPET) on a bicycle, measured in watts. |
| VO2peak during CPET | From enrollment to the end of treatment at 6 months | 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). |
| Fasted blood HbA1c | From enrollment to the end of treatment at 6 months | Hemoglobin A1c (HbA1c): Reported as a percentage (%). |
| Fasting insulin | From enrollment to the end of treatment at 6 months | Fasting Insulin: Reported in micro-international units per milliliter (μIU/mL) or picomoles per liter (pmol/L). |
| Kidney function (creatinine) | From enrollment to the end of treatment at 6 months | Creatinine: Reported in milligrams per deciliter (mg/dL) or micromoles per liter (μmol/L). |
Countries
Belgium
Contacts
CONTACTDominique Hansen, Full Professor
CONTACTJitske Vandersmissen, PhD student
PRINCIPAL_INVESTIGATORDominique Hansen, Full professor
Hasselt University
PRINCIPAL_INVESTIGATORKoen Cuypers, Assistant professor
Hasselt University
Outcome results
None listed