A Randomized Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Nonalcoholic Fatty Liver Disease
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Enrollment
- 65
- Locations
- 3
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
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.
Time Frame: 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 Outcomes
- The effect of a low calorie diet on steatosis and steatohepatitis.(30 days post-operatively)
- 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)