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

NCT ID: NCT01645852

Last Updated: 2017-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Disease Hepatic Steatosis Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Control

No specified diet for one week prior to hepatic resection.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

Optifast 800

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Optifast 800

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard J. Barth, MD

Role: PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Locations

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UMass Memorial Medical Center

Worcester, Massachusetts, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Fletcher Allen Health Care

Burlington, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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DMS 12052

Identifier Type: -

Identifier Source: org_study_id

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