The Effect of Exercise on the Brain in Type 2 Diabetes (SAINT)

Hasselt University

Status: Invitation-only

Conditions: Type 2 Diabetes

Treatments: Other: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06734546

B1152024000012

1129225N (Other Grant/Funding Number)

BOF24KP05 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 75 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

High intensity exercise training group

Experimental group

Description:

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

Treatment:

Other: Exercise intervention

Moderate intensity exercise training group

Experimental group

Description:

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

Treatment:

Other: Exercise intervention

Control group

No Intervention group

Description:

This arm won't receive exercise training