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Effect of Preoperative Supplementation in Insulin Resistance

NCT ID: NCT00657124

Last Updated: 2008-04-14

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

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-12-31

Brief Summary

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To elucidate the effect of preoperative supplementation of carbohydrate and branched-chain amino acids on postoperative insulin resistance in patients undergoing hepatic resection, we set a randomized trial.

Detailed Description

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Twenty-six patients with hepatectomy due to a live tumor were prospectively randomized to receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient or not.

Conditions

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Liver Disease

Keywords

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AEN

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient

Group Type EXPERIMENTAL

Aminolevan EN

Intervention Type DIETARY_SUPPLEMENT

The present study used carbohydrate and BCAA-enriched soft-powder nutrient-mixture for preoperative supplementation. Supplementation with Aminolevan EN (100 g per day) started at two weeks prior to the surgery under the careful monitoring of compliance.

2

receive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

Interventions

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Aminolevan EN

The present study used carbohydrate and BCAA-enriched soft-powder nutrient-mixture for preoperative supplementation. Supplementation with Aminolevan EN (100 g per day) started at two weeks prior to the surgery under the careful monitoring of compliance.

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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No receive, normal diet

Eligibility Criteria

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Inclusion Criteria

* The present study employed 26 patients, who underwent elective liver resection for hepatocellular carcinoma or adenocarcinoma.

Exclusion Criteria

* body weight loss greater than 10 per cent during 6 months prior to the surgery
* distant metastasis
* or seriously impaired function of vital organs due to respiratory, renal or heart disease
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kochi University

OTHER

Sponsor Role lead

Responsible Party

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Kochi University

Principal Investigators

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Takehiro Okabayashi, MD

Role: STUDY_DIRECTOR

Kochi Medical School, Kochi University

Locations

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Kochi Medical School

Nankoku, Kohasu-Okocho, Japan

Site Status

Countries

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Japan

Other Identifiers

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Kochi University

Identifier Type: -

Identifier Source: secondary_id

PEA-AP-01

Identifier Type: -

Identifier Source: org_study_id