Clinical trial NCT06734546: The Effect of Exercise on the Brain in Type 2 Diabetes
Official title: The Effect of Exercise of High Vs. Moderate Intensity on the Brain in Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 2 Diabetes
Keywords: type 2 diabetes
exercise intervention
brain
cognition
neurometabolism
dementia
cerebral perfusion
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Jessa Hospital
name: Research Foundation Flanders
First posted: 2024-12-16
Enrollment: 75
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* no insulin therapy
* 30-75 years old
* right handed
* physically inactive

Exclusion Criteria:

* left handed
* 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

Primary outcomes:
measure: Neurometabolite levels
timeFrame: From enrollment to the end of treatment at 6 months
measure: Changes in arterial spin labelling measured by means of magnetic resonance imaging (MRI)
timeFrame: From enrollment to the end of treatment at 6 months
Secondary outcomes:
measure: Levels of neurodegenerative blood biomarkers
timeFrame: From enrollment to the end of treatment at 6 months
measure: Blood lipid profile
timeFrame: From enrollment to the end of treatment at 6 months
measure: Brain volume
timeFrame: From enrollment to the end of treatment at 6 months
measure: Diffusion-weighted magnetic resonance imaging
timeFrame: From enrollment to the end of treatment at 6 months
measure: Fasted blood glucose
timeFrame: From enrollment to the end of treatment at 6 months
measure: Kidney function (eGFR)
timeFrame: From enrollment to the end of treatment at 6 months
measure: Cognitive function: MoCA
timeFrame: From enrollment to the end of treatment at 6 months
measure: Cognitive function: Face recognition test
timeFrame: From enrollment to the end of treatment at 6 months
measure: Cognitive function: Object location test
timeFrame: From enrollment to the end of treatment at 6 months
measure: Cognitive function: Trail making test
timeFrame: From enrollment to the end of treatment at 6 months
measure: Cognitive function: Stroop colour and word test
timeFrame: From enrollment to the end of treatment at 6 months
measure: Cognitive function: Rey auditory verbal learning test
timeFrame: From enrollment to the end of treatment at 6 months
measure: Subjective cognitive function
timeFrame: From enrollment to the end of treatment at 6 months
measure: Peak load during CPET
timeFrame: From enrollment to the end of treatment at 6 months
measure: VO2peak during CPET
timeFrame: From enrollment to the end of treatment at 6 months
measure: Fasted blood HbA1c
timeFrame: From enrollment to the end of treatment at 6 months
measure: Fasting insulin
timeFrame: From enrollment to the end of treatment at 6 months
measure: Kidney function (creatinine)
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, Full professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Koen Cuypers, Assistant professor
role: PRINCIPAL_INVESTIGATOR
References: