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RecruitingNCT06734546SAINTUpdated Mar 31, 2026

The Effect of Exercise on the Brain in Type 2 Diabetes

An interventional study of Exercise intervention in Type 2 Diabetes, sponsored by Hasselt University. Recruiting at 1 site in Belgium. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-31.

Sponsored by Hasselt University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
30 Years to 75 Years
Sex
All
01

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
02

Conditions studied

  • Type 2 Diabetes

Keywords

  • type 2 diabetes
  • exercise intervention
  • brain
  • cognition
  • neurometabolism
  • dementia
  • cerebral perfusion
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 75 is close to the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Hasselt University is the lead sponsor of 204 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • type 2 diabetes
  • no insulin therapy
  • 30-75 years old
  • physically inactive

Exclusion criteria

Exclusion Criteria:

  • MRI
  • psychological disorders
  • exogenous insulin therapy
  • history of coma, , 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, (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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    High intensity exercise training group

    This arm will receive 6 months of exercise training at high intensity (105% VT2)

    Other: Exercise intervention

  • Experimental
    Moderate intensity exercise training group

    This arm will receive 6 months of exercise training at moderate intensity (60% VT2)

    Other: Exercise intervention

  • No intervention
    Control group

    This arm won't receive exercise training

Interventions

  • OtherExercise intervention

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

06

What researchers measure

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 months

  2. 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 months

Secondary 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 months

  2. 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 months

  3. Brain volume

    Total and regional (LHIPP, mPFC, PCC) brain volumes

    Time frame: From enrollment to the end of treatment at 6 months

  4. 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 months

  5. Fasted blood glucose

    Fasting Glucose: Reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L).

    Time frame: From enrollment to the end of treatment at 6 months

  6. Kidney function (eGFR)

    Estimated Glomerular Filtration Rate (eGFR): Reported in milliliters per minute per 1.73 m² (mL/min/1.73 m²).

    Time frame: From enrollment to the end of treatment at 6 months

  7. Cognitive function: MoCA

    Cognitive function as assessed by the Montreal Cognitive Assessment (MoCA), scored on a scale of 0-30.

    Time frame: From enrollment to the end of treatment at 6 months

  8. Cognitive function: Face recognition test

    Cognitive function as assessed by the Face Recognition Test, reported as the number of correct identifications.

    Time frame: From enrollment to the end of treatment at 6 months

  9. Cognitive function: Object location test

    Cognitive function as assessed by the Object Location Test, reported as the number of correct placements.

    Time frame: From enrollment to the end of treatment at 6 months

  10. 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.

    Time frame: From enrollment to the end of treatment at 6 months

  11. 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.

    Time frame: From enrollment to the end of treatment at 6 months

  12. 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.

    Time frame: From enrollment to the end of treatment at 6 months

  13. Subjective cognitive function

    Cognitive function as assessed by the Cognitive Failure Questionnaire, scored on a scale of 0-100.

    Time frame: From enrollment to the end of treatment at 6 months

  14. Peak load during CPET

    The maximum load achieved during cardiopulmonary exercise testing (CPET) on a bicycle, measured in watts.

    Time frame: From enrollment to the end of treatment at 6 months

  15. 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).

    Time frame: From enrollment to the end of treatment at 6 months

  16. Fasted blood HbA1c

    Hemoglobin A1c (HbA1c): Reported as a percentage (%).

    Time frame: From enrollment to the end of treatment at 6 months

  17. Fasting insulin

    Fasting Insulin: Reported in micro-international units per milliliter (μIU/mL) or picomoles per liter (pmol/L).

    Time frame: From enrollment to the end of treatment at 6 months

  18. Kidney function (creatinine)

    Creatinine: Reported in milligrams per deciliter (mg/dL) or micromoles per liter (μmol/L).

    Time frame: From enrollment to the end of treatment at 6 months

07

Study locations

1 of 1 sites recruiting
  • Hasselt University
    Hasselt, Limburg 3500, Belgium
    Recruiting
    • Dominique Hansen, Full professor · Contactdominique.hansen@uhasselt.be · +3211292126
    • Koen Cuypers, Assistant professor · Contactkoen.cuypers@uhasselt.be · +3211269316
    • Jitske Vandersmissen, PhD student · Sub investigator
    • Robin Heemels, PhD student · Sub investigator
    • Melina Hehl, PhD · Sub investigator
    • Ilse Dewachter, Full professor · Sub investigator
    • Koen Cuypers, Assistant professor · Principal investigator
    • Stefan Sunaert, Professor · Sub investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06734546
Lead sponsor
Hasselt University
Collaborators
Universitaire Ziekenhuizen KU Leuven, Jessa Hospital, Research Foundation Flanders
Responsible party
Dominique Hansen (Full professor, Hasselt University) — Principal investigator
First posted
Dec 16, 2024
Start date
Nov 8, 2024
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Mar 31, 2026

Study contacts

Dominique Hansen, Full Professor
Contact
dominique.hansen@uhasselt.be
+3211292126
Jitske Vandersmissen, PhD student
Contact
jitske.vandersmissen@uhasselt.be
+3211268387
Dominique Hansen, Full professor
principal investigator · Hasselt University
Koen Cuypers, Assistant professor
principal investigator · Hasselt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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