Exercise and Cerebral Hemodynamics in MAFLD.
NCT05520697 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2022-08-30
Summary
Arterial stiffness and endothelial dysfunction present in metabolic associated fatty liver disease (MAFLD) confer increased cardiovascular risk, which represents the leading cause of mortality in this group of patients.
Mechanisms involved in the cardiovascular complications of MAFLD have recently been found to also affect cerebral blood flow altering cerebral hemodynamics in MAFLD subjects. These alerations can be detected through transcranial Doppler, which measures markers of cerebrovascular vasoconstriction, which indicates cerebrovascular autoregulation.16 These abnormalities are related to vascular disease in MAFLD, which plays an essential role in ischemic stroke and cognitive impairment, which explains why MAFLD patients had lower scores on cognitive function tests.17 Nonetheless, there are no studies evaluating the effect of lifestyle interventions (specifically exercise) on cerebral hemodynamics in patients with MAFLD, however, it has been shown that in other pathologies that share pathophysiological similarities with NAFLD there are beneficial changes in this outcome. An example of the above is chronic heart failure and liver cirrhosis, where physical exercise attenuates the inflammatory cascade (decrease in IL6, IL8, IL12, TNFa), and decreases the activation of the renin-angiotensin system with a direct effect on endothelial function improvement. Our research group also documented that a 12-week physical training program acts on this mechanism and has a beneficial effect on cerebral hemodynamics evaluated by transcranial Doppler in patients with liver cirrhosis, which leads to an improvement in neuropsychometric tests.18 Improvement in the previously described pathways through a 16-week physical training program in MAFLD patients could potentially improve alterations in cerebral blood flow, cognitive function, endothelial function, body composition, and the degree of liver steatosis and fibrosis. This outcome has never been assessed in MAFLD patients undergoing exercise. In addition, although there are studies that demonstrate the impact of diet and exercise, most have evaluated these interventions individually, which represents a limitation when implementing them as a multidisciplinary intervention.
Therefore, our hypothesis is that a 16-week physical training program will improve cerebral hemodynamic parameters in patients with metabolic-associated fatty liver compared to a control group without a physical training program.
Conditions
- Non-alcoholic Fatty Liver Disease
Interventions
- BEHAVIORAL
-
Nutritional intervention
Nutritional treatment with caloric restriction.
- BEHAVIORAL
-
Mental exercise.
Mental exercise.
- BEHAVIORAL
-
Physical training.
Exercise.
Sponsors & Collaborators
-
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
lead OTHER
Principal Investigators
-
Ricardo Macías-Rodríguez, MD,MSc,PhD · Department of Gastroenterology, INCMNSZ
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-12-01
- Primary Completion
- 2023-12-31
- Completion
- 2024-12-31
Countries
- Mexico
Study Locations
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