The Effect of Exercise on the Brain in Type 2 Diabetes
ConditionType 2 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-75
SponsorHasselt University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
type 2 diabetes
no insulin therapy
30-75 years old
physically inactive
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise intervention
Other interventionThe exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: High intensity exercise training groupExperimental treatment 1 intervention
Group B: Moderate intensity exercise training groupExperimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
From enrollment to the end of treatment at 6 months2
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 monthsSecondary outcomes
1
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 months2
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 months3
Brain volume
Total and regional (LHIPP, mPFC, PCC) brain volumes
Time frame
From enrollment to the end of treatment at 6 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hasselt University
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborator
Jessa Hospital
Collaborator
Research Foundation Flanders
Collaborator
Source ClinicalTrials.gov