NCT00657124

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
Last Updated

April 14, 2008

Status Verified

April 1, 2008

Enrollment Period

8 months

First QC Date

April 7, 2008

Last Update Submit

April 11, 2008

Conditions

Liver Disease

Keywords

AEN

Outcome Measures

Primary Outcomes (1)

  • to evaluate the total amount of insulin required for glycemic control after hepatic resection

    total amount of insulin required

Secondary Outcomes (1)

  • to investigate the trends of postoperative blood glucose levels and the incidence of severe hypoglycemia (< 40 mg/dL) by using artificial pancreas during intensive care unit stay

    hypoglycemia

Study Arms (2)

1

EXPERIMENTAL

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

Dietary Supplement: Aminolevan EN

2

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Aminolevan ENDIETARY_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.

1
PlaceboDIETARY_SUPPLEMENT

placebo

Also known as: No receive, normal diet
2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kochi Medical School

Nankoku, Kohasu-Okocho, 783-8505, Japan

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Takehiro Okabayashi, MD

    Kochi Medical School, Kochi University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 14, 2008

Study Start

April 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 14, 2008

Record last verified: 2008-04

Locations

JP(1)