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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Steatosis; Nonalcoholic Fatty Liver Disease; Steatohepatitis
• Intervention / Treatment: Dietary supplement: Optifast 800

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No specified diet for one week prior to hepatic resection.
Active Comparator: Low calorie diet; 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.	Dietary supplement: Optifast 800; Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	30 days post-operatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of a low calorie diet on steatosis and steatohepatitis.	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.	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.	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.	30 days post-operatively

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Investigators: Principal Investigator: Richard J. Barth, MD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 18, 2012
• First Posted (Estimate): July 20, 2012

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: DMS 12052