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

NCT ID: NCT03186859

Last Updated: 2023-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-09
• Study Completion Date: 2020-08-30

Brief Summary

Approximately 90% of people undergoing bariatric surgery have NAFLD, which is a condition where fat accumulates in the liver and can lead to inflammation and scarring. It mostly causes no symptoms, however, in the most advanced cases there is an increased risk of liver cancer or liver failure.

NAFLD is currently managed by weight loss and treating associated diseases such as diabetes. No medicines have been licensed to directly treat it but bariatric surgery has been shown to be usually beneficial, although it is unknown whether some operations are better than others. It is also unclear whether this is due to general weight loss or other factors.

This study will be conducted in a hospital setting and aims to determine what changes in liver fat and fat processing occur after pre-operative low calorie diet and the two most common types of bariatric surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.

Participants will have ten study visits, four of which may be combined with NHS appointments. Participants will undergo investigations including MRI scans to measure changes in NAFLD and DEXA scans to measure changes in fat and fat-free mass (FFM). Participants will also undergo mixed meal testing to which stable isotopes (deuterated water and 13c-palmitate) will be added to allow changes in fat processing to be detected. In addition to samples taken as part of NHS care, blood, urine, liver and fat (visceral and subcutaneous (abdominal and gluteal)) will be used for research. Visits will take place before and after low calorie diet and bariatric surgery.

Conditions

Non-Alcoholic Fatty Liver Disease; Non Alcoholic Fatty Liver; Bariatric Surgery Candidate; Obesity, Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Roux-en-Y Gastric Bypass (RYGB) surgery

Group Type: ACTIVE_COMPARATOR

Roux-en-Y Gastric Bypass (RYGB) surgery

Intervention Type: PROCEDURE

RYGB operation using surgeons' standard technique

Sleeve Gastrectomy (SG) surgery

Group Type: ACTIVE_COMPARATOR

Sleeve Gastrectomy (SG) surgery

Intervention Type: PROCEDURE

SG surgery using surgeons' standard technique

Interventions

Roux-en-Y Gastric Bypass (RYGB) surgery

RYGB operation using surgeons' standard technique

Intervention Type: PROCEDURE

Sleeve Gastrectomy (SG) surgery

SG surgery using surgeons' standard technique

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Tomlinson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

University of Oxford

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

219190

Identifier Type: -

Identifier Source: org_study_id