Resistance exercise and non-alcoholic fatty liver disease
| ISRCTN | ISRCTN26705810 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26705810 |
| Secondary identifying numbers | 6955; G0802536 |
- Submission date
- 23/04/2010
- Registration date
- 23/04/2010
- Last edited
- 29/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Michael Trenell
Scientific
Scientific
Westgate Road
Newcastle Upon Tyne
NE4 6BE
United Kingdom
Study information
| Study design | Non-randomised interventional prevention and treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please contact kate.hallsworth@ncl.ac.uk to request a patient information sheet |
| Scientific title | The effect of resistance exercise on metabolism and liver lipid in people with non-alcoholic fatty liver disease |
| 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(s) | County Durham and Tees Valley 2 REC approved on the 28th September 2009 (ref: 09/H0908/48) |
| 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 |
| Primary outcome measure | 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 study start date | 01/08/2009 |
| Overall study end date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 28; UK Sample Size: 28 |
| 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 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
- England
- United Kingdom
Study participating centre
Westgate Road
Newcastle Upon Tyne
NE4 6BE
United Kingdom
NE4 6BE
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Midwifery Research Dept
Leazes Wing
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Research council
Diabetes UK (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- DIABETES UK LIMITED, British Diabetic Association
- Location
- United Kingdom
Medical Research Council (MRC) (UK) (ref: G0802536)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
