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| Name | Class |
|---|---|
| Royal Liverpool University Hospital | OTHER_GOV |
| University of Surrey | OTHER |
| Imperial College London | OTHER |
| Royal Surrey County Hospital NHS Foundation Trust |
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This project examines the effects of a 4 month structured exercise intervention program in patients with non-alcoholic fatty liver disease (NAFLD). We will examine changes in total and depot-specific (i.e.in different tissues, liver, muscle and pancreas)fat. We will correlate these with measurements of the insulin from the liver. The hypothesis is that by reducing fat in these specific depots we can reduce insulin resistance and prevent progression to diabetes.
Exercise program: We are asking people to take part in a supervised exercise program for 4 months. This involves on average a weekly supervised exercise bout plus other unsupervised exercise bouts at home. We will ensure participants are physically able to embark on this by taking their medical history, physical examination and validated questionnaire (PARQ). This program is for the benefit on the patients' long term health.
MR imaging to assess fat: occassionally these may pick up anomalies which require further investigation. A radiologist will screen the abdominal images and GP will be informed on anything requiring further investigation.
No radiation is received during MR imaging.
Physiological studies: Patients will be asked to attend for 2 non-consecutive days before and after the exercise intervention. Regular blood samples will be required as apart of these investigations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Unsupervised exercise training This group will be given 1 hour lifestyle counseling by the exercise trainer after which they will have no contact with the exercise trainer to the end of the intervention period. The exercise intervention will be offered to the subjects once the post studies are completed. |
|
| lifestyle counseling and exercise | Experimental | Supervised exercise training Four months exercise training intervention will be either gym-based or patients will choose the mode of exercise that suits their lifestyle. Patients will be encouraged to exercise four times per week for 30-45 min at 60-80 % of maximal heart rate, with a 5 min warm-up and warm-down. Participants will be given free access to a variety of affiliated sports centres and will use the Wellness Key system, a software program that enables researchers to remotely track the exercise activity of participants very accurately. To ensure compliance with rest or exercise, all participants of both groups will have their mean physical activity level in 2 non-consecutive weeks evaluated with an ambulatory accelerometer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unsupervised exercise training | Behavioral | The patients will be given lecture on lifestyle changes and its benefitial effects on health at the begining of the study by the exercise trainer. There will be no conatct with the exercise trainer for the period of intervention for 4 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in liver and muscle fat | Tissue triglyceride content, or steatosis, will be accurately and non-invasively quantified in vivo using localized proton magnetic resonance spectroscopy (1H MRS). | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in liver function tests | Biochemial measurements of the liver enzymes will be measured pre and post intervention period | 4 months |
| Changes in lipid profiles | Total cholesterol, triglyceride and high density lipoprotien concentrations in fasting state will be measured pre and post intervention period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Cuthbertson, BSc PhD MRCP | University of Liverpool | Study Director |
| Fariba Shojaee-Moradie, BSc PhD | University of Surrey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Surrey County Hospital | Guildford | Surrey | GU16 7UJ | United Kingdom | ||
| University of Surrey |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38847589 | Derived | Cuthbertson DJ, Keating SE, Pugh CJA, Owen PJ, Kemp GJ, Umpleby M, Geyer NG, Chinchilli VM, Stine JG. Exercise improves surrogate measures of liver histological response in metabolic dysfunction-associated steatotic liver disease. Liver Int. 2024 Sep;44(9):2368-2381. doi: 10.1111/liv.15947. Epub 2024 Jun 7. | |
| 27583475 | Derived |
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| OTHER |
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|
| Supervised exercise training | Behavioral | Patients will be encouraged to exercise four times per week for 30-45 min at 60-80 % of maximal heart rate, with a 5 min warm-up and warm-down. Participants will be given free access to a variety of affiliated sports centres and will use the Wellness Key system, a software program that enables researchers to remotely track the exercise activity of participants very accurately. To ensure compliance with rest or exercise, all participants of both groups will have their mean physical activity level in 2 non-consecutive weeks evaluated with an ambulatory accelerometer. |
|
| 4 months |
| Changes in body weight and anthropometric measurements | Body weight and waist to hip ratio will be measured pre and post intervention period. | 4 months |
| Hepatic insulin sensitivity | Half of the study cohort i.e. 30 individuals,15 exercise and 15 controls, will have peripheral and hepatic insulin sensitivity determined using a two-stage hyperinsulinaemic, euglycaemic clamp and use of deuterated glucose (2H2-glucose | 4 months |
| VLDL-TG kinetics | The other half of the study cohort i.e. 30 individuals, 15 exercise and 15 controls, will have VLDL1 and VLDL2 TG kinetics determined using 5H2 glycerol bolus. | 4 months |
| Guildford |
| Surrey |
| GU27WG |
| United Kingdom |
| John Moores University | Liverpool | L3 2ET | United Kingdom |
| University of Liverpool | Liverpool | L69 3GE | United Kingdom |
| Royal Liverpool University Hospital | Liverpool | L7 8XP | United Kingdom |
| Liverpool University | Liverpool | L9 7AL | United Kingdom |
| Imperial College London | London | W12 0HS | United Kingdom |
| Shojaee-Moradie F, Cuthbertson DJ, Barrett M, Jackson NC, Herring R, Thomas EL, Bell J, Kemp GJ, Wright J, Umpleby AM. Exercise Training Reduces Liver Fat and Increases Rates of VLDL Clearance But Not VLDL Production in NAFLD. J Clin Endocrinol Metab. 2016 Nov;101(11):4219-4228. doi: 10.1210/jc.2016-2353. Epub 2016 Sep 1. |
| 27439593 | Derived | Pugh CJ, Sprung VS, Jones H, Richardson P, Shojaee-Moradie F, Umpleby AM, Green DJ, Cable NT, Trenell MI, Kemp GJ, Cuthbertson DJ. Exercise-induced improvements in liver fat and endothelial function are not sustained 12 months following cessation of exercise supervision in nonalcoholic fatty liver disease. Int J Obes (Lond). 2016 Dec;40(12):1927-1930. doi: 10.1038/ijo.2016.123. Epub 2016 Jul 21. |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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