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CompletedNCT00657124Updated Apr 14, 2008

Effect of Preoperative Supplementation in Insulin Resistance

A Phase 4 interventional study of Aminolevan EN and Placebo in Liver Disease, sponsored by Kochi University. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2008-04-14.

Sponsored by Kochi University · Phase 4, Interventional, and Health services research

Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Randomized
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Liver Disease

Keywords

  • AEN
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 26 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Kochi University is the lead sponsor of 18 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    1

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

    Dietary Supplement: Aminolevan EN

  • Placebo comparator
    2

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

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementAminolevan 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.

  • Dietary supplementPlacebo

    placebo

    Also known as: No receive, normal diet

06

What researchers measure

Primary outcomes

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

    Time frame: 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

    Time frame: hypoglycemia

07

Study locations

1 site
  • Kochi Medical School
    Nankoku-City, Kohasu-Okocho 783-8505, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00657124
Lead sponsor
Kochi University
First posted
Apr 14, 2008
Start date
Apr 2007
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Apr 14, 2008

Study contacts

Takehiro Okabayashi, MD
study director · Kochi Medical School, Kochi University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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