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

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01645852
• Other study ID #: DMS 12052
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: February 6, 2017
• Start date: June 2012
• Est. completion date: December 2016

Study information

• Verified date: February 2017
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease
• Steatohepatitis

Intervention

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.

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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