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
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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COMPLETED
NA
65 participants
INTERVENTIONAL
2012-06-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Control
No specified diet for one week prior to hepatic resection.
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.
Optifast 800
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.
Eligibility Criteria
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Inclusion Criteria
* Clinical indication for a therapeutic liver resection
* BMI of 25 kg/m2 or greater
* Informed Consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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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
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Countries
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Other Identifiers
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DMS 12052
Identifier Type: -
Identifier Source: org_study_id
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