Hepatic Steatosis, Nonalcoholic Fatty Liver Disease, Steatohepatitis
Conditions
Brief summary
The purpose of this study is to measure the effect of a short-term low calorie diet on patients with a Body Mass Index (BMI) over 25 who are undergoing liver surgery.
Interventions
DIETARY_SUPPLEMENTOptifast 800
Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.
Sponsors
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or greater * Clinical indication for a therapeutic liver resection * BMI of 25 kg/m2 or greater * Informed Consent
Exclusion criteria
* Inability to comply with the pre-op diet * Patients who have lost 5% or more of their usual body weight over the preceding one month * Female patients of childbearing age who have a positive pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of a low calorie diet on intra-operative blood loss, technical ease of hepatic transection, complication rates (including infectious complications), length of stay and mortality in patients undergoing liver surgery. | 30 days post-operatively | Intra-operative blood loss will be strictly quantified. Units of autologous or donor blood transfused will be recorded. The surgeon will assess the ease of liver mobilization and parenchymal transection using a 1-5 scale where 1 is easy and 5 is hard. Post-operative complications, length of stay and mortality will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of a low calorie diet on steatosis and steatohepatitis. | 30 days post-operatively | Using tissue from hepatic parenchyma adjacent to resected neoplasms steatosis and steatohepatitis will be evaluated by a pathologist blinded to dietary intervention. Steatosis will be defined as mild, moderate or severe if 5-33%, 34-66%, or \>66% of hepatocytes contain fat inclusions. Steatohepatitis will be defined using NAFLD (Non-Alcoholic Fatty Liver Disease) Activity Score (NAS) as an NAS 4 or greater, with \<4 defined as no steatohepatitis. |
| The mechanism of decreased steatosis in patients undergoing a low-calorie pre-op diet by measuring levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids. | 30 days post-operatively | Levels of expression of molecules involved in the de novo synthesis, hepatic uptake and degradation of lipids will be measured to evaluate the mechanism of decreased steatosis. |
Countries
United States
Outcome results
None listed