Non-alcoholic fatty liver disease (NAFLD) - Clinical trial details 

Recruitment status:

Recruiting

Primary Sponsor:

University of Oxford

Recruitment countries:

United Kingdom

Health condition studied:

Bariatric Surgery Candidate

URL:

Link to the clinical trial website

About the trial

Interventions:

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

Key inclusion and exclusion 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)
  

• Age minimum:  18 Years
• Age maximum:  75 Years
• Gender:  All

Primary outcomes:

Change in liver fat content

Secondary outcomes:

change in body mass index (BMI)
Change in fat mass
Change in functional strength
Change in lean mass
change in status of metabolic diseases (e.g. diabetes) / metabolic disease risk scores
Change in the incorporation of 13C (from dietary fat) into CO2
change in weight
changes in fasting and post-prandial peptides/proteins (e.g. PYY, GLP-1, insulin)
Changes in fasting and postprandial plasma glucose concentration
Changes in fasting and postprandial plasma lipid concentration
Changes in relative contributions of pathways involved in lipid homeostasis
changes in subcutaneous, visceral and pancreatic fat
complications, re-operation, mortality
Expression changes (gene/protein) in adipose tissue biopsies
Hepatic fatty acid synthesis

Target sample size:

32

Study type:

Interventional

Study design:

Contacts:

• Name:   Jeremy Tomlinson, MD PhD
• Address: 
• Phone: 
• Email: 
• Affiliation:  University of Oxford

• Name:   Jeremy Tomlinson, MD PhD
• Address: 
• Phone:  0044 1865 857359
• Email:  jeremy.tomlinson@ocdem.ox.ac.uk
• Affiliation: 

• Name:   Jeremy W Tomlinson, MD PhD
• Address: 
• Phone:  44(0)1865 857359
• Email:  jeremy.tomlinson@ocdem.ox.ac.uk
• Affiliation: 

Technical details

Scientific title:

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

Sources of monetary support:

Please refer to primary and secondary sponsors

Secondary sponsors:

Main ID:

NCT03186859

Secondary ID:

219190

Register:

ClinicalTrials.gov

Date of registration:

23/05/2017

Date of first enrollment:

June 9, 2017

Last refreshed:

3 July 2017