NCT05699863

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
119mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress36%
Oct 2020Jan 2036

Study Start

First participant enrolled

October 6, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

April 19, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
10.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2036

Expected
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

5.2 years

First QC Date

April 19, 2022

Last Update Submit

February 21, 2024

Conditions

NAFLDObesityExtracellular VesiclesWeight Loss

Outcome Measures

Primary Outcomes (6)

  • Effect of weight loss on organ steatosis

    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.

    36 months

  • Effect of weight loss on plasma alanine transaminase

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

    36 months

  • Effect of weight loss on BMI

    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.

    36 months

  • Effect of weight loss on total body fat

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

    36 months

  • Effect of weight loss on the homeostasis model assessment for insulin resistance

    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.

    36 months

  • Effect of weight loss on plasma aspartate transaminase

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

    36 months

Secondary Outcomes (2)

  • Extracellular vesicles as biomarkers in disease monitoring

    36 months

  • Extracellular vesicles as biomarkers for NAFLD diagnosis

    36 months

Study Arms (3)

Metabolically unhealthy obese (Intervention group)

EXPERIMENTAL

Obese (BMI: 30.0 - 39.9) participants with non-alcoholic fatty liver disease and metabolic syndrome.

Behavioral: Lifestyle intervention

Metabolically healthy obese (Comparison group 1)

NO INTERVENTION

Obese individuals considered metabolically healthy based on them not presenting non-alcoholic fatty liver disease or metabolic syndrome.

Healthy normal weight (Comparison group 2)

NO INTERVENTION

Normal weight individuals without non-alcoholic fatty liver disease or metabolic syndrome.

Interventions

Lifestyle interventionBEHAVIORAL

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.

Metabolically unhealthy obese (Intervention group)

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aalborg University Hospital

Aalborg, North Jutland, 9000, Denmark

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityWeight Loss

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Aase Handberg, Prof MD DMSc

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study has three three groups, including obese (BMI 30,0 - 39,9 kg/m2) individuals (obese group) and lean (BMI 18,5 - 24,9 kg/m2) age and sex-matched control individuals (control group). Based on initial enrolment into the obese group, individuals with NAFLD (\>5% hepatic steatosis) and metabolic syndrome (according to International Diabetes Foundation (IDF) consensus) will undergo a 4-5 month lifestyle intervention (intervention group).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 19, 2022

First Posted

January 26, 2023

Study Start

October 6, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

January 31, 2036

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

There is a general wish too share Individual Participant Data (IPD), however, due to stringent data and personal data protection considerations, it will not be possible unless data can be fully anonymised in the future.

Locations

DK(1)