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NCT Number: NCT06734546

The Effect of Exercise on the Brain in Type 2 Diabetes

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

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Key information

Conditions

Type 2 Diabetes Brain Diseases Central Nervous System Diseases Dementia Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Mental Disorders Metabolic Diseases Nervous System Diseases Neurocognitive Disorders Nutritional and Metabolic Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Hasselt, Limburg, 3500, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise intervention

Other

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

Primary outcomes

  1. Neurometabolite levels

    Time frame: 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).

  2. Changes in arterial spin labelling measured by means of magnetic resonance imaging (MRI)

    Time frame: 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 outcomes

  1. Levels of neurodegenerative blood biomarkers

    Time frame: 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.

  2. Blood lipid profile

    Time frame: 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

  3. Brain volume

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

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

  4. Diffusion-weighted magnetic resonance imaging

    Time frame: 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

  5. Fasted blood glucose

    Time frame: 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).

  6. Kidney function (eGFR)

    Time frame: 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).

  7. Cognitive function: MoCA

    Time frame: 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.

  8. Cognitive function: Face recognition test

    Time frame: 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.

  9. Cognitive function: Object location test

    Time frame: 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.

  10. Cognitive function: Trail making test

    Time frame: 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.

  11. Cognitive function: Stroop colour and word test

    Time frame: 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.

  12. Cognitive function: Rey auditory verbal learning test

    Time frame: 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.

  13. Subjective cognitive function

    Time frame: 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.

  14. Peak load during CPET

    Time frame: 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.

  15. VO2peak during CPET

    Time frame: 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).

  16. Fasted blood HbA1c

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

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

  17. Fasting insulin

    Time frame: 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).

  18. Kidney function (creatinine)

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

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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Jessa Hospital
  • Research Foundation Flanders
  • Universitaire Ziekenhuizen KU Leuven

Registry information

Official study title

The Effect of Exercise of High vs. Moderate Intensity on the Brain in Type 2 Diabetes

Acronym: SAINT

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 16, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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