Type 2 DiabetesSAINTNCT06734546
The Effect of Exercise on the Brain in Type 2 Diabetes
A study testing Exercise intervention in people with Type 2 Diabetes, run by Hasselt University at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Nov 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- type 2 diabetes
- no insulin therapy
- 30-75 years old
- physically inactive
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Hasselt, Limburg, 3500
Dominique Hansen, Full professor, +3211292126, dominique.hansen@uhasselt.be
Koen Cuypers, Assistant professor, +3211269316, koen.cuypers@uhasselt.be
About this study
Official title: The Effect of Exercise of High vs. Moderate Intensity 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?
Read more
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
- Conditions
- Type 2 Diabetes
- Being tested
- Exercise intervention
- Keywords
- type 2 diabetes, exercise intervention, brain, cognition, neurometabolism, dementia, cerebral perfusion
- Medical subject headings
- Diabetes Mellitus, Type 2, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| High intensity exercise training group | Experimental | This arm will receive 6 months of exercise training at high intensity (105% VT2) Receives: Other: Exercise intervention |
| Moderate intensity exercise training group | Experimental | This arm will receive 6 months of exercise training at moderate intensity (60% VT2) Receives: Other: Exercise intervention |
| Control group | No intervention | This arm won't receive exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From enrollment to the end of treatment at 6 months
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
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (18)
Levels of neurodegenerative blood biomarkers
Tau (pg/mL), amyloid beta (pg/mL), S100B (ng/mL), neurofilament light (pg/mL) etc.
Measured: From enrollment to the end of treatment at 6 months
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
Measured: From enrollment to the end of treatment at 6 months
Brain volume
Total and regional (LHIPP, mPFC, PCC) brain volumes
Measured: From enrollment to the end of treatment at 6 months
Diffusion-weighted magnetic resonance imaging
DWI will be used to measure differences in Brownian motion of water molecules within the brain
Measured: From enrollment to the end of treatment at 6 months
Fasted blood glucose
Fasting Glucose: Reported in milligrams per deciliter (mg/dL) or millimoles per liter (mmol/L).
Measured: From enrollment to the end of treatment at 6 months
Kidney function (eGFR)
Estimated Glomerular Filtration Rate (eGFR): Reported in milliliters per minute per 1.73 m² (mL/min/1.73 m²).
Measured: From enrollment to the end of treatment at 6 months
Cognitive function: MoCA
Cognitive function as assessed by the Montreal Cognitive Assessment (MoCA), scored on a scale of 0-30.
Measured: From enrollment to the end of treatment at 6 months
Cognitive function: Face recognition test
Cognitive function as assessed by the Face Recognition Test, reported as the number of correct identifications.
Measured: From enrollment to the end of treatment at 6 months
Cognitive function: Object location test
Cognitive function as assessed by the Object Location Test, reported as the number of correct placements.
Measured: From enrollment to the end of treatment at 6 months
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.
Measured: From enrollment to the end of treatment at 6 months
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.
Measured: From enrollment to the end of treatment at 6 months
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.
Measured: From enrollment to the end of treatment at 6 months
Subjective cognitive function
Cognitive function as assessed by the Cognitive Failure Questionnaire, scored on a scale of 0-100.
Measured: From enrollment to the end of treatment at 6 months
Peak load during CPET
The maximum load achieved during cardiopulmonary exercise testing (CPET) on a bicycle, measured in watts.
Measured: From enrollment to the end of treatment at 6 months
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).
Measured: From enrollment to the end of treatment at 6 months
Fasted blood HbA1c
Hemoglobin A1c (HbA1c): Reported as a percentage (%).
Measured: From enrollment to the end of treatment at 6 months
Fasting insulin
Fasting Insulin: Reported in micro-international units per milliliter (μIU/mL) or picomoles per liter (pmol/L).
Measured: From enrollment to the end of treatment at 6 months
Kidney function (creatinine)
Creatinine: Reported in milligrams per deciliter (mg/dL) or micromoles per liter (μmol/L).
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start8 Nov 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Jessa Hospital, Research Foundation Flanders
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Dominique Hansen, Full professor, Principal investigator, Hasselt UniversityKoen Cuypers, Assistant professor, Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734546
- Sponsor's protocol ID
- B1152024000012
- Other IDs
- 1129225N, BOF24KP05
- Acronym
- SAINT
- Status last verified
- Mar 2026
- First submitted
- 25 Nov 2024
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise of High vs. Moderate Intensity on the Brain in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06734546
- Acronym / sponsor ID
- SAINT / B1152024000012
- Conditions
- Type 2 Diabetes
- Keywords
- type 2 diabetes, exercise intervention, brain, cognition, neurometabolism, dementia, cerebral perfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Jessa Hospital, Research Foundation Flanders
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High intensity exercise training group | Experimental | Other: Exercise interventionThis arm will receive 6 months of exercise training at high intensity (105% VT2) |
| Moderate intensity exercise training group | Experimental | Other: Exercise interventionThis arm will receive 6 months of exercise training at moderate intensity (60% VT2) |
| Control group | No intervention | –This arm won't receive exercise training |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- type 2 diabetes
- no insulin therapy
- 30-75 years old
- physically inactive
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise interventionThe exercise intervention entails 6 months of supervised exercise on a hometrainer at high or moderate intensity, 3 times per week | Other | High intensity exercise training group, Moderate intensity exercise training group |
Primary outcome
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).
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
18 secondary outcomes
Levels of neurodegenerative blood biomarkers
Time frame: From enrollment to the end of treatment at 6 months
Blood lipid profile
Time frame: From enrollment to the end of treatment at 6 months
Brain volume
Time frame: From enrollment to the end of treatment at 6 months
Diffusion-weighted magnetic resonance imaging
Time frame: From enrollment to the end of treatment at 6 months
Fasted blood glucose
Time frame: From enrollment to the end of treatment at 6 months
Kidney function (eGFR)
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: MoCA
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Face recognition test
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Object location test
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Trail making test
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Stroop colour and word test
Time frame: From enrollment to the end of treatment at 6 months
Cognitive function: Rey auditory verbal learning test
Time frame: From enrollment to the end of treatment at 6 months
Subjective cognitive function
Time frame: From enrollment to the end of treatment at 6 months
Peak load during CPET
Time frame: From enrollment to the end of treatment at 6 months
VO2peak during CPET
Time frame: From enrollment to the end of treatment at 6 months
Fasted blood HbA1c
Time frame: From enrollment to the end of treatment at 6 months
Fasting insulin
Time frame: From enrollment to the end of treatment at 6 months
Kidney function (creatinine)
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dominique Hansen, Full professor principal investigator
Hasselt University
Koen Cuypers, Assistant professor principal investigator
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise intervention in people with Type 2 Diabetes, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique Hansen, Full Professor (+3211292126, dominique.hansen@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurometabolite levels (time frame: From enrollment to the end of treatment at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.