Prognostic Significance of Fatty Liver Disease in Bariatric Patients (PROMETHEUS)

Esbjerg Hospital - University Hospital of Southern Denmark

Status: Enrolling

Conditions: Metabolic Encephalopathy; Non-alcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease; Obesity, Morbid

Treatments: Procedure: Bariatric surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03535142

S-20170210

Details and patient eligibility

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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,200 participants in 2 patient groups

Intervention

Experimental group

Description:

The intervention is bariatric surgery (Roux en Y gastric bypass or gastric sleeve operation).

Treatment:

Procedure: Bariatric surgery

Control

No Intervention group

Description:

Age, BMI and co-morbidity matched group who do not undergo surgery.