Effects of short-term energy restriction on liver lipids
| ISRCTN | ISRCTN65605485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65605485 |
| Secondary identifying numbers | 11770 |
- Submission date
- 17/05/2012
- Registration date
- 17/05/2012
- Last edited
- 12/07/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims:
Did you know that when people put on excess weight there is an increased danger of unseen liver injury? Fatty liver is up to five times more likely to occur in obese people than those who are a healthy weight. Fatty liver disease can exist without any symptoms, but it can also progress to serious liver damage. It has a range of disease states from non-threatening fat build-up (steatosis), to inflammatory steatohepatitis and fibrosis (cirrhosis). We know weight loss helps to reduce fatty liver, so disease progression can be reversed at this stage. However, once the disease reaches the fibrosis stage the liver damage is irreversible. Progression of the disease is thought to be affected by the body's resistance to its own insulin, coping strategies for excess fat, and automatic immune defences causing inflammation. These interactions are complex and we are not exactly sure what happens. We are investigating these interactions, to see what happens when an obese person follows a short-term very strict diet.
Who can participate?
Patients accepted for weight-loss surgery at Derby Hospitals NHS Foundation Trust.
What does the study involve?
Participants will follow a two-week diet of around 800 kcal/day either the standard hospital pre-operative diet or a meal replacement plan. Before the diet blood tests will be taken, as well as body weight. During the diet a food and drink diary will be completed. After the diet (at the time of the weight-loss surgery) - body weight will be measured, a further blood sample will be taken and biopsies of liver and fat
What are the possible benefits and risks of participating?
Overall, the study should help to identify the effects of the short-term diet on the liver, and wider effects on the body. It should also identify which type of diet is of most benefit to patients undergoing weight-loss surgery. As the participants follow the standard care pathway there are minimal additional risks. However, taking biopsies is an extra procedure and the surgeon will minimise any discomfort and manage any risks involved in this process.
Where is the study run from?
From the University of Nottingham with the co-operation of the regional Bariatric Surgical Service at Derby Hospitals NHS Foundation Trust.
When is the study starting and how long is it expected to run for?
Study recruitment started in May 2012 and will continue until June 2014, or until we have reached the target number of 100 participants, if sooner.
Who is funding the study?
Schools of Biomedical Sciences and Graduate Entry Medicine and Health, University of Nottingham.
Biotechnology and Biological Sciences Research Council (BBSRC).
Who is the main contact?
Prof. Ian Macdonald
ian.macdonald@nottingham.ac.uk
Contact information
Scientific
Professor of Metabolic Physiology
School of Biomedical Sciences
University of Nottingham Medical School
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
| Phone | +44 (0)115 951 5151 |
|---|---|
| ian.macdonald@nottingham.ac.uk |
Study information
| Study design | Randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN65605485_PIS_08Jun12_V1.2.doc |
| Scientific title | Effects of short-term energy restriction on liver lipid content, metabolism and inflammatory status in severely obese adults |
| Study acronym | EnR-Lin |
| Study objectives | A two week period of energy restriction will effect a reduction in liver lipid content, gene expression and plasma inflammatory markers, in severely obese individuals, relative to the level of energy restriction achieved. |
| Ethics approval(s) | West Midlands - Coventry and Warwickshire, Health Research Authority, 25/01/2012, ref: 12/WM/0017 |
| Health condition(s) or problem(s) studied | Hepatology, Surgery |
| Intervention | Participants will be assigned randomly, to one of two intervention groups to undertake an energy restrictive diet for two weeks pre-operatively: 1. The Derby Hospitals standard pre-bariatric surgical diet 2. Meal replacement diet using nutritional supplements Both diets will offer approximately 800kcal/d. No follow-up post-diet, participants reverted to the standard clinical care pathway. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Fatty Liver Assessment is measured using histological assessment of tissue biopsy and NASH Clinical Research Network scoring system definitions at time of surgery (post-diet). |
| Secondary outcome measures | 1. Body Weight Change is measured using a Marsden MPMS-300 high capacity weighing scale, before the diet, at the pre-op clinic, and after the diet, on the day of surgery 2. Diet Compliance is measured using a study-specific self-reported questionnaire with visual analogue scale on the day of surgery (post-diet) |
| Overall study start date | 01/10/2011 |
| Completion date | 30/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 100 |
| Key inclusion criteria | 1. Patients accepted for weight loss surgery at Derby Hospitals NHS Foundation Trust 2. Male and female participants 3. Lower age limit = 18 years, no upper age limit |
| Key exclusion criteria | 1. Secondary NAFLD 2. Diabetes mellitus treated by insulin, GLP1 or pioglitazone 3. Excess alcohol intake (exceeding national recommendations) 4. Patients receiving anti-inflammatory medication 5. Pregnancy and lactation 6. Any other condition judged by the investigative team to be clinically significant Exclusions recommended by LighterLife (meal replacement plan): 7.1. Some cardiac conditions (including heart failure, arrhythmias, valve disease, requiring treatment) 7.2. Some cerebrovascular conditions. (Patients who have suffered cerebrovascular disease may participate if the following conditions are met; more than six months has passed and the patients condition is stable) 7.3. Schizophrenia, delusional and bipolar disorder, psychosis 7.4. Epilepsy or history of seizure 7.5. Kidney or liver disease (severe) 7.6. Total lactose intolerance 7.7. Type 1 diabetes 7.8. Anorexia or bulimia or other eating disorder undergoing or awaiting treatment. 7.9. Porphyria 7.10. Taking prescribed anticoagulants, digoxin, lithium or monoamine oxidase inhibitors (MAOIs) 7.11. Unstable angina 7.12. Major depressive disorder |
| Date of first enrolment | 08/05/2012 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Derby
DE22 3NE
United Kingdom
Sponsor information
University/education
Research Innovation Services
Kings Meadow Campus
Lenton Lane
Nottingham
NG7 2NR
England
United Kingdom
| Phone | +44 (0)115 951 5151 |
|---|---|
| ian.macdonald@nottingham.ac.uk | |
| Website | http://www.nottingham.ac.uk/ |
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Research council
Government organisation / National government
- Alternative name(s)
- UKRI - Biotechnology And Biological Sciences Research Council, BBSRC UK, BBSRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1.2 | 08/06/2012 | 09/01/2017 | No | Yes |
| Results article | results | 01/08/2017 | Yes | No |
Additional files
- ISRCTN65605485_PIS_08Jun12_V1.2.doc
- Uploaded 09/01/2017
Editorial Notes
12/07/2018: IPD sharing statement added.
10/07/2018: Publication reference added.
09/01/2017: The overall trial dates have been updated from 08/05/2012 - 30/06/2014 to 01/10/2011 - 30/09/2014. In addition, the trial participating centre, IPD sharing plan and publication and dissemination plan have been added, and the timepoints and methods of measurement have been added to the outcome measures.
05/01/2017: No publications found in PubMed, verifying study status with principal investigator.
15/03/2013: The anticipated end date for this trial was updated from 31/12/2013 to 30/06/2014
