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

Primary Purpose

Nonalcoholic Fatty Liver Disease, Hepatic Steatosis, Steatohepatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optifast 800
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nonalcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMass Memorial Medical Center
  • Dartmouth-Hitchcock Medical Center
  • Fletcher Allen Health Care

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Low calorie diet

Arm Description

No specified diet for one week prior to hepatic resection.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 17, 2012
Last Updated
February 6, 2017
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01645852
Brief Title
A Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
Official Title
A Randomized Phase II Study of the Effect of a Low Calorie Diet on Patients Undergoing Liver Resection
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Fatty Liver Disease, Hepatic Steatosis, Steatohepatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No specified diet for one week prior to hepatic resection.
Arm Title
Low calorie diet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Optifast 800
Intervention Description
Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
30 days post-operatively
Secondary Outcome Measure Information:
Title
The effect of a low calorie diet on steatosis and steatohepatitis.
Description
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.
Time Frame
30 days post-operatively
Title
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.
Description
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.
Time Frame
30 days post-operatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard J. Barth, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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