A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection

Not Applicable

Completed

• Conditions: Steatohepatitis; Nonalcoholic Fatty Liver Disease; Hepatic Steatosis
• Interventions: Dietary Supplement: Optifast 800

• Registration Number: NCT01645852
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-07-17
• Study First Submitted QC: 2012-07-18
• Study First Posted: 2012-07-20
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low calorie diet	Optifast 800	Low calorie diet (five units of Optifast 800 {Nestle Nutrition, Vevey, Switzerland} plus an unlimited volume of calorie free fluids per day) for one week prior to hepatic resection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Fletcher Allen Health Care; 🇺🇸 Burlington, Vermont, United States

Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States