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

NCT01645852 | Completed DMC

• 1 other identifier: DMS 12052
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 3

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.

Conditions

Nonalcoholic Fatty Liver Disease; Hepatic Steatosis; Steatohepatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

Control

NO INTERVENTION

No specified diet for one week prior to hepatic resection.

Low calorie diet

ACTIVE COMPARATOR

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

Interventions

Optifast 800 DIETARY_SUPPLEMENT

Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.

Low calorie diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or greater
• Clinical indication for a therapeutic liver resection
• BMI of 25 kg/m2 or greater
• Informed Consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

Study Sites (3)

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Fletcher Allen Health Care

Burlington, Vermont, 05401, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Richard J. Barth, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2012
• First Posted: July 20, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 8, 2017

Record last verified: 2017-02

Locations

US (3)