Effects of Dietary Intervention and Surgery on NAFLD (Non-Alcoholic Fatty Liver Disease)

Plain-language summary

This study examined the effects of Roux-en-Y gastric bypass and sleeve gastrectomy surgery in people with non-alcoholic fatty liver disease (NAFLD) who were already scheduled for bariatric (obesity) surgery. It enrolled participants aged 18 to 75 with a body mass index between 35 and 55. It was conducted as a study without an assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

University of Oxford

Intervention

Roux-en-Y Gastric Bypass (RYGB) surgery, Sleeve Gastrectomy (SG) surgery

Start date

6/9/2017

Estimated completion

8/30/2020

Countries

United Kingdom

Related genes

Locations

• Oxford, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Bariatric surgery is already planned for the participant
* Participant is willing and able to give informed consent for participation in the study.
* Aged ≥18 or ≤75 years.
* Body Mass Index ≥35 ≤55 kg/m2

Exclusion Criteria:

* Contraindication to MRI
* Prior or current participation in a CTIMP that could affect study results
* History of alcoholism or a greater than recommended weekly alcohol intake (14 units per week)
* History of albumin allergy
* Anticoagulant treatment
* Pregnant or nursing mothers
* Type 2 Diabetes
* A liver disease other than NAFLD
* Histological confirmation of lack of NAFLD on liver biopsy
* Large hiatus hernia (that would prohibit Sleeve Gastrectomy)
* Active gastrooesophageal reflux disease (that would prohibit Sleeve Gastrectomy)
* Active malabsorptive intestinal disease (that would prohibit Roux-en-Y Gastric Bypass surgery)