Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001087842
Ethics application status
Approved
Date submitted
10/10/2012
Date registered
10/10/2012
Date last updated
18/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The independent effects of diet and exercise in the progression of chronic liver disease
Scientific title
Distinct effects of diet and exercise on liver histology and cardiometabolic risk factors in non-alcoholic steatohepatitis
Secondary ID [1] 281371 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-alcoholic fatty liver disease (NAFLD) 287594 0
Condition category
Condition code
Diet and Nutrition 287923 287923 0 0
Obesity
Oral and Gastrointestinal 287929 287929 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A group based circuit exercise training program (EX) (without changes to dietary intake), supervised by an exercise physiologist, involving one hour of training three times per week for six months. The circuit training consists of 15 resistance exercises with training intensity fixed at 50% of one repetition maximum (1-RM), reassessed monthly. The 1-RM test involves the participant lifting the heaviest weight possible whereby they can perform only 1 repetition. This weight is then halved and set as the weight used for the training session. This assessment is individualised for each muscle group and repeated monthly so that any increases in strength (1-RM) during the program are accounted for and the intensity remains stable at 50% 1-RM relative to improving strength.
Intervention code [1] 285837 0
Lifestyle
Comparator / control treatment
diet-induced (DI) energy restriction (without changes to physical activity) with the aim of 5-10% body weight loss over 4 months and maintenance of weight for a further two months. The Dietary group will be prescribed an individualised 500kCal/day energy deficit diet by an accredited practicing Dietitian for the first 2 months with an aim to decrease weight by 0.5kg per week. The dietary composition aims to provide 45% carbohydrate, 35% fat and 20% protein. Participants have weekly appointments with the Dietitian for the first 4 months, followed by fortnightly appointments for 2 months whereby energy prescription is adjusted to ensure maintenance of weight loss. Diet diaries and diet histories are taken to assess food intake.
Control group
Active

Outcomes
Primary outcome [1] 288136 0
Liver Histology: A liver biopsy will be performed at baseline and at 6 months to assess steatosis, lobular inflammation, hepatocyte ballooning and fibrosis. The histological features of disease will be used in a validated scoring system (NAFLD activity score). Change in individual features and scores will be monitored.
Timepoint [1] 288136 0
6 months
Secondary outcome [1] 299480 0
Hepatic and Peripheral Insulin resistance: Sites and severity of insulin resistance will be assessed using a euglycaemic hyperinsulinemic clamp technique with stable glucose tracer infusion to detect both liver and muscle insulin resistance. The clamp assessment requires infusion of insulin and labelled glucose and blood draws every 5-10 mins for 2 hours until steady state infusions are reached.
Timepoint [1] 299480 0
6 months

Eligibility
Key inclusion criteria
Biopsy proven Nonalcoholic fatty liver disease
BMI>25kg/m2
Non-diabetic
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included the presence of other liver diseases or evidence of cirrhosis, alcohol consumption > 40 g/day (males) or > 20 g/day (females), and diabetes

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
It is an open label study as concealment of intervention is not possible. Participants are recruited from hospital outpatient clinics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once consented, patients are randomised to either diet or exercise intervention by computer generated random number
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2009
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
30/06/2012
Date of last data collection
Anticipated
Actual
30/12/2012
Sample size
Target
20
Accrual to date
Final
17
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 286124 0
Government body
Name [1] 286124 0
National Health and Medical Research Council
Country [1] 286124 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Ipswich Rd
Woolloongabba, Qld 4102
Country
Australia
Secondary sponsor category [1] 284938 0
University
Name [1] 284938 0
The University of Queensland
Address [1] 284938 0
Diamantina Institute
Princess Alexandra Hospital
Ipswich Rd Woolloongabba Qld 4102
Country [1] 284938 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288174 0
Princess Alexandra Hospital
Ethics committee address [1] 288174 0
Ethics committee country [1] 288174 0
Australia
Date submitted for ethics approval [1] 288174 0
Approval date [1] 288174 0
23/06/2006
Ethics approval number [1] 288174 0
PAH2006/046

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2277 2277 0 0
/AnzctrAttachments/363131-Hickman et al 2013.pdf (Publication)

Contacts
Principal investigator
Name 34809 0
Dr Ingrid Hickman
Address 34809 0
Dept Nutrition and Dietetics, Princess Alexandra Hospital Ipswich Rd Woolloongabba Qld 4102
Country 34809 0
Australia
Phone 34809 0
+61 7 3176 5588
Fax 34809 0
Email 34809 0
[email protected]
Contact person for public queries
Name 18056 0
Ingrid Hickman
Address 18056 0
Dept Nutrition and Dietetics
Ground Floor Building 15
Princess Alexandra Hospital
Ipswich Rd Woolloongabba Qld 4102
Country 18056 0
Australia
Phone 18056 0
+61 7 3176 7132
Fax 18056 0
Email 18056 0
[email protected]
Contact person for scientific queries
Name 8984 0
Dr Ingrid Hickman
Address 8984 0
Dept Nutrition and Dietetics
Ground Floor Building 15
Princess Alexandra Hospital
Ipswich Rd Woolloongabba Qld 4102
Country 8984 0
Australia
Phone 8984 0
+61 7 3176 7132
Fax 8984 0
Email 8984 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.