The Effect of Exercise on the Brain in Type 2 Diabetes

Not Applicable

• Conditions: Type 2 Diabetes

• Registration Number: NCT06734546
• Lead Sponsor: Hasselt University

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study Start: 2024-11-08
• Study First Submitted: 2024-11-25
• Study First Submitted QC: 2024-12-13
• Last Update Submitted: 2024-12-13
• Study First Posted: 2024-12-16
• Last Update Posted: 2024-12-16
• Primary Completion: 2026-02
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Levels of neurodegenerative blood biomarkers	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.
Blood lipid profile	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
Brain volume	From enrollment to the end of treatment at 6 months	Total and regional (LHIPP, mPFC, PCC) brain volumes
Diffusion-weighted magnetic resonance imaging	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
Fasted blood glucose	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).
Kidney function (eGFR)	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).
Cognitive function: MoCA	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.
Cognitive function: Face recognition test	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.
Cognitive function: Object location test	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.
Cognitive function: Trail making test	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.
Cognitive function: Stroop colour and word test	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.
Cognitive function: Rey auditory verbal learning test	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.
Subjective cognitive function	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.
Peak load during CPET	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.
VO2peak during CPET	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).
Fasted blood HbA1c	From enrollment to the end of treatment at 6 months	Hemoglobin A1c (HbA1c): Reported as a percentage (%).
Fasting insulin	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).
Kidney function (creatinine)	From enrollment to the end of treatment at 6 months	Creatinine: Reported in milligrams per deciliter (mg/dL) or micromoles per liter (μmol/L).

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Hasselt, Limburg, Belgium