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ACTIVE NOT RECRUITING
NCT05699863
NA

The MULTISITE Study

Sponsor: Aalborg University Hospital

View on ClinicalTrials.gov

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.

Official title: A Multidisciplinary Approach to Screening for Obesity Complications - The MULTISITE Study

Key Details

Gender

All

Age Range

30 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2020-10-06

Completion Date

2036-01-31

Last Updated

2024-02-22

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Lifestyle intervention

Lifestyle intervention in the form of individualised dietitian consultation with the overall goal of weight loss. Intervention includes one initial consultation with a dietician of 1 hour and 15 minutes where participants receive a personalised diet-plan customised to the participants everyday life. After the initial consultation, the participants attend 10 "follow-ups" of about 25 minutes that are spread out over 4-5 months.

Locations (1)

Aalborg University Hospital

Aalborg, North Jutland, Denmark