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Recruiting Not applicable

The Effect of Exercise on the Brain in Type 2 Diabetes

NCT06734546 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2024-11-08
Last updated
2026-03-31

Condition(s) studied

Type 2 Diabetes

Investigational drug(s) / intervention(s)

Exercise intervention

Exercise intervention: The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week

Study 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

Sex
ALL
Min age
30 Years
Max age
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

Primary outcome measure(s)

  • 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

Trial sites (1)

FacilityCityRegionStatus
Hasselt University Hasselt Limburg Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06734546 on ClinicalTrials.gov ↗ ← All trials in Belgium