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Recruiting
NCT05699863
The MULTISITE Study
Conditions: NAFLD, Obesity, Extracellular Vesicles, Weight Loss
Sex: All
Ages: 30 Years – 60 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 90
Sponsor: Aalborg University Hospital
Location: Denmark
Summary
This study will investigate potential correlations and relationships between obesity and organ-specific complications, including non-alcoholic fatty liver disease (NAFLD), non-alcoholic fatty pancreas disease (NAFPD) and fatty kidney.
Furthermore, it will investigate how and if a lifestyle-induced weight-loss intervention decreases liver fat and improve NAFLD.Furthermore, the study will investigate if extracellular vesicles (EVs) can be used as a biomarker for early detection of any of the above-mentioned by comparing obese individuals with NAFLD and metabolic syndrome with both normal weight controls and obese individuals without NAFLD and metabolic syndrome.
Lastly, it will investigate if weight changes and the resulting improvement of NAFLD are accompanied by changes in liver-specific extracellular vesicle (EV) phenotypes.
Eligibility Criteria
Inclusion Criteria:Age 30-60BMI between 30,0 - 39,9 kg/m2.Signed informed consent.Metabolic syndromeNAFLDWishes to participate in a weight reduction program.Exclusion Criteria:Diabetes or any significant endocrine, heart, kidney, liver, or malignant disease.Pregnancy, planned pregnancy, or breast-feeding during the trial.Alcohol abuse or abuse of recreational drugsMedical treatment (systemic glucocorticoids, steatosis-inducing drugs, antibiotics up to two months prior to inclusion, or chemotherapy) or participation in clinical trials other than this.Excessive weight loss within the last three months (defined as more than 10 kilograms).Contraindications for MRI and dual energy x-ray absorptiometry (DEXA)scanning.Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the trial procedures.
Source: ClinicalTrials.gov (NCT05699863). StuddyBuddy aggregates publicly available trial information.