Clinical trial

The MULTISITE Study

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05699863

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age30 Years to 60 Years

SexAll

Healthy volunteersAccepted

ConditionNAFLD, Obesity, Extracellular Vesicles, Weight Loss

Full registry criteria

Inclusion Criteria: * Age 30-60 * BMI between 30,0 - 39,9 kg/m2. * Signed informed consent. * Metabolic syndrome * NAFLD * Wishes 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 drugs * Medical 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.

Treatments and study arms

Lifestyle intervention

Behavioral

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.

Primary outcomes

Effect of weight loss on organ steatosis36 months

Changes in steatosis of the liver, pancreas and kidneys assessed by magnetic resonance imaging (proton density fat fraction) between baseline, during weight loss, and after weight loss.

Effect of weight loss on plasma alanine transaminase36 months

Changes in plasma alanine transaminase (IU/L) between baseline, during weight loss, and after weight loss.

Effect of weight loss on BMI36 months

Changes in BMI between baseline, during weight loss, and after weight loss. Weight and height will be combined to report BMI in kg/m\^2.

Effect of weight loss on total body fat36 months

Changes in total body fat (%) as assessed by dual dual energy x-ray absorptiometry between baseline, during weight loss, and after weight loss.

Effect of weight loss on the homeostasis model assessment for insulin resistance36 months

Changes in Homeostasis model assessment for insulin resistance (HOMA) between baseline, during weight loss, and after weight loss. Insulin (pmol/L) and plasma glucose (mmol/L) will be combined to calculate HOMA using the iterative structural model.

Effect of weight loss on plasma aspartate transaminase36 months

Changes in plasma aspartate transaminase (IU/L) between baseline, during weight loss, and after weight loss.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Aalborg University Hospital🇩🇰 Aalborg, North Jutland, Denmark

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