Prognostic Significance of Fatty Liver Disease in Bariatric Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bariatric surgery.
- Who it may be relevant to
- Registry conditions: Non-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid, Non-alcoholic Steatohepatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Prospective non-randomized intervention case control study on patients with a BMI \> 35. The intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. The overall aim is to examine prevalence of the spectrum of fatty liver disease (NAFLD) in these patients and the prognostic significance of NAFLD.
Interventions
- Procedure Bariatric surgery
Roux en y gastric bypass or gastric sleeve operation
Primary outcome measures
- Number of participants who will die during the follow up period in case and control group [Time frame: 10 years follow up after inclusion]
Secondary outcome measures (4)
- Number of participant who will experience progressive fatty liver disease in case and control group [Time frame: 10 years follow up after inclusion]
- Change in continuous reaction time measurement after bariatric surgery [Time frame: 10 years follow up after inclusion]
- Change in EEG after bariatric surgery [Time frame: 24 months after surgery]
- Change in intelligence quotient after bariatric surgery [Time frame: 24 months efter surgery]
Eligibility criteria
Inclusion Criteria case group:
- Age > 18 years
- BMI >35 kg/m2 and referred for bariatric surgery at Hospital of South West Jutland, Denmark
- Able to give written informed consent.
Inclusion criteria control group:
- Age > 18 years
- BMI >35 kg/m2 with no wish to undergo bariatric surgery.
- Able to give written informed consent.
Exclusion criteria
- Active viral hepatitis
- Not willing or able to consent
- Contraindications to liver biopsy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Denmark · 1 center
- Hospital of Southwest Jutland — Esbjerg
Publications
- Wernberg CW, Indira Chandran V, Lauridsen MM, Skytthe MK, Hansen CD, Hansen JK, Gronkjaer LL, Jacobsen BG, Di Caterino T, Detlefsen S, Thiele M, Guiliani AM, Villesen IF, Leeming DJ, Karsdal M, Graversen JH, Krag A. Ability of soluble TREM2 and PRO-C3 as biomarkers to predict changes in MASLD activity. JHEP Rep. 2025 Apr 22;7(8):101432. doi: 10.1016/j.jhepr.2025.101432. eCollection 2025 Aug. PMID 40677693
Identifiers
NCT: NCT03535142 · S-20170210