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

Recruitment status:

Recruiting

Primary Sponsor:

East Lancashire Hospitals NHS Trust

Recruitment countries:

United Kingdom

Health condition studied:

1. Hepatic steatosis or intra-hepatic fat 2. Non alcoholic fatty liver disease
Digestive System

URL:

Link to the clinical trial website

About the trial

Interventions:

10 participants will undergo 2 chemical shift magnetic resonance scans using the clinical magnetic resonance scanner at Royal Blackburn Hospital.

These scans will be performed at least one day apart.

On visit 1, participants will also be asked to provide a blood sample for assessment of liver function, glycaemic control and lipid profile. Weight, height and hip-to-waist ratio will also be recorded. From this body mass index will be calculated.

No further blood samples will be acquired on the second visit.

Intra-person results will be statistically analysed for agreement using the Bland Altmann method with a priori variance levels of 0.2 deemed acceptable.

Key inclusion and exclusion criteria:

• Inclusion criteria: 1. Participants must be able to receive and understand verbal and written information regarding the study and give written, informed consent.
  2. Participants should have features associated with intra-hepatic fat such as elevated BMI.
  3. >18 years old
  4. Male or female
• Exclusion criteria: 1. Persons under 18 years of age
  2. Conditions in which the supine position and breath holds required for MR scanning are not possible
  3. Persons who might not adequately understand verbal explanations or written information given in English, or who have special communication needs
  4. Persons with contraindications to MR imaging- presence of cardiac pacemaker/artificial heart valve/aneurysm clips/metallic fragments in eyes/cochlear implants
  5. Pre-existing chronic liver pathology such as haemachromatosis, viral hepatitis or primary hepatic malignancy

• Age minimum: 
• Age maximum: 
• Gender:  Both

Primary outcomes:

Intrahepatic fat fraction as measured by 2 Chemical Shift Magnetic Resonance scans greater than 24 hours apart.

Secondary outcomes:

1. Indocyanine Green Plasma Disappearance Rate and Retention at 15 minutes, measured using a PULSiON Indocyanine Green Clearance Testing Device. This will be measured at visit 1 and 4 weeks later
2. BMI, Height, Weight and Hip to Waist ratio, measured at visit 1 and 2
3. Assessment of Liver function, Glycaemic control and Lipid profile, including Bilirubin, AST, ALT, ALP GGT, HbA1c, Random Glucose, Triglycerides and Cholesterol at visit 1.

Target sample size:

10

Study type:

Observational

Study design:

Single centre. Observational feasibility study. (Diagnostic)

Contacts:

• Name: Daren Subar
• Address:  Department of Hepatopancreatobiliary Surgery Royal Blackburn Hospital Haslingden Road
• Phone:  01254 263555
• Email:  daren.subar@elht.nhs.uk
• Affiliation: 

• Name: Linda Gregson
• Address:  Research and Development Department Royal Blackburn Hospital Haslingden Road
• Phone:  01254 263555
• Email:  linda.gregson@elht.nhs.uk
• Affiliation: 

Technical details

Scientific title:

A precision and reproducibility assessment of intra-hepatic fat quantification by chemical shift magnetic resonance

Sources of monetary support:

Rosemere Cancer Foundation

Secondary sponsors:

Main ID:

ISRCTN74994614

Secondary ID:

Study Protocol v2.0

Register:

ISRCTN

Date of registration:

01/07/2016

Date of first enrollment:

01/06/2016

Last refreshed:

17 October 2016