NCT05699863Active, not recruiting
The MULTISITE Study
A Multidisciplinary Approach to Screening for Obesity Complications - The MULTISITE Study
Source: ClinicalTrials.gov · Last updated 22 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 19 Apr 2022
- Start date
- 6 Oct 2020
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05699863
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 6 Oct 2020 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Diabetes or any significant endocrine, heart, kidney, liver, or malignant disease.
Lab values
- 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.
Other
- Pregnancy, planned pregnancy, or breast-feeding during the trial.
- 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.
Who the study is looking for
- 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.
Age in the registry: 30 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
Related publications
- Extracellular Vesicle Surface Protein Profiling in Metabolic Dysfunction-associated Steatotic Liver Disease in Obesity.J Extracell Biol · 2026 · PMID 42683217
- Dynamic changes in body fat distribution, ectopic fat, and related metabolic improvement in response to weigt loss in obesity.Sci Rep · 2026 · PMID 42399294
This page is information, not medical advice. Discuss any trial with your doctor.