Condition category
Digestive System
Date applied
23/04/2010
Date assigned
23/04/2010
Last edited
29/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Trenell

ORCID ID

Contact details

Westgate Road
Newcastle Upon Tyne
NE4 6BE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

6955; G0802536

Study information

Scientific title

The effect of resistance exercise on metabolism and liver lipid in people with non-alcoholic fatty liver disease

Acronym

Study hypothesis

The purpose of the study is to characterise the effects of resistance exercise upon factors which influence the development and progression of non-alcoholic fatty liver disease (NAFLD). The primary aim is to observe whether performing resistance exercise reduces liver lipid content in people with NAFLD. The secondary aims are to understand the influence of resistance exercise upon factors which influence the development of NAFLD: insulin sensitivity, lipid oxidation, regional adiposity and cytokine production.

Ethics approval

County Durham and Tees Valley 2 REC approved on the 28th September 2009 (ref: 09/H0908/48)

Study design

Non-randomised interventional prevention and treatment trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Not available in web format, please contact kate.hallsworth@ncl.ac.uk to request a patient information sheet

Condition

Topic: Metabolic and Endocrine, Oral and Gastrointestinal; Subtopic: Metabolic and Endocrine (all Subtopics); Disease: Metabolic & Endocrine (not diabetes), Hepatology

Intervention

Participants will be assigned to the exercise or control group. The exercise group will undergo 8 weeks of resistance training 3 times per week. The intensity of the programme will be tailored to each individual and be increased progressively over the 8 weeks. The control group will continue with standard clinical care. Follow up length: 4 months.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

A quantitative measure of liver fat will be made using H magnetic resonance spectroscopy. Primary and secondary outcome measures will be made at baseline and after the 8 week exercise intervention/8 week control period.

Secondary outcome measures

1. Insulin sensitivity
2. Lipid oxidation
3. Cytokine production
4. Regional adiposity
5. Body composition

Primary and secondary outcome measures will be made at baseline and after the 8 week exercise intervention/8 week control period.

Overall trial start date

01/08/2009

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed NAFLD or raised liver enzymes
2. Type 2 diabetes (diet or metformin controlled)
3. Body mass index (BMI) between 25 - 35 kg/m^2
4. Aged 18 - 70 years
5. Subjects should not already take part in regular exercise

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 28; UK Sample Size: 28

Participant exclusion criteria

1. Subjects with kidney disease or in vivo ferrous metal
2. Subjects that have other pre-existing medical conditions which could prevent them from exercising 3 x per week
3. Subjects with type 2 diabetes on insulin or insulin sensitising treatments
4. Subjects with advanced liver disease

Recruitment start date

01/08/2009

Recruitment end date

01/06/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Westgate Road
Newcastle Upon Tyne
NE4 6BE
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

Midwifery Research Dept
Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Government

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Research council

Funder name

Diabetes UK (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Medical Research Council (MRC) (UK) (ref: G0802536)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21708823

Publication citations

  1. Results

    Hallsworth K, Fattakhova G, Hollingsworth KG, Thoma C, Moore S, Taylor R, Day CP, Trenell MI, Resistance exercise reduces liver fat and its mediators in non-alcoholic fatty liver disease independent of weight loss., Gut, 2011, 60, 9, 1278-1283, doi: 10.1136/gut.2011.242073.

Additional files

Editorial Notes