Clinical trial

Prognostic Significance of Fatty Liver Disease in Bariatric Patients

Recruiting now · Not applicable · 1 countries · Registry ID NCT03535142

Recruiting nowNot applicableInterventional

What this study is about

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.

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

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionNon-Alcoholic Fatty Liver Disease, Metabolic Encephalopathy, Obesity, Morbid, Non-alcoholic Steatohepatitis

Full registry 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

Treatments and study arms

Bariatric surgery

Procedure

Roux en y gastric bypass or gastric sleeve operation

Primary outcomes

Number of participants who will die during the follow up period in case and control group10 years follow up after inclusion

Difference in mortality between cases and controls with various NAFLD severity on biopsy.

Study locations

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

Hospital of Southwest Jutland🇩🇰 Esbjerg, Denmark

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Mette Lauridsen, PostdocContact

Email · Call 61661192