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Effect of Preoperative Supplementation in Insulin Resistance

Sponsor
Kochi University (Other)
Overall Status
Completed
CT.gov ID
NCT00657124
Collaborator
(none)
26
Enrollment
1
Location
2
Arms
8
Duration (Months)
3.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Aminolevan EN
  • Dietary Supplement: Placebo
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Preoperative Oral Supplementation of Carbohydrate and Branched-Chain Amino Acids-Enriched Nutrient Improves Insulin Resistance in Patients With Hepatectomy; Prospective Randomized Clinical Trial by Using Artificial Pancreas
Study Start Date :
Apr 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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

Dietary Supplement: 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.
Placebo Comparator: 2

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

Dietary Supplement: Placebo
placebo
Other Names:
  • No receive, normal diet

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Kochi Medical School Nankoku-City Kohasu-Okocho Japan 783-8505

    Sponsors and Collaborators

    • Kochi University

    Investigators

    • Study Director: Takehiro Okabayashi, MD, Kochi Medical School, Kochi University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00657124
    Other Study ID Numbers:
    • PEA-AP-01
    • Kochi University
    First Posted:
    Apr 14, 2008
    Last Update Posted:
    Apr 14, 2008
    Last Verified:
    Apr 1, 2008
    Keywords provided by , ,
    AEN
    Additional relevant MeSH terms:
    Liver Diseases
    Insulin Resistance

    Study Results

    No Results Posted as of Apr 14, 2008