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NCT Number: NCT01645852

A 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.

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Key information

Conditions

Nonalcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Hepatic Steatosis Liver Diseases Non-alcoholic Fatty Liver Disease Steatohepatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center, Worcester, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 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 outcomes

  1. The effect of a low calorie diet on steatosis and steatohepatitis.

    Time frame: 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.

  2. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 20, 2012
Registry last updated
Feb 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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