Hepatology, Surgery Surgery
Conditions
Interventions
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
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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 patient?s 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
United Kingdom
Outcome results
None listed