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Effect of Preoperative Supplementation in Insulin Resistance

Phase 4
Completed
Conditions
Liver Disease
Interventions
Dietary Supplement: Aminolevan EN
Dietary Supplement: Placebo
Registration Number
NCT00657124
Lead Sponsor
Kochi University
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
26
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
1Aminolevan ENreceive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient
2Placeboreceive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient
Primary Outcome Measures
NameTimeMethod
to evaluate the total amount of insulin required for glycemic control after hepatic resectiontotal amount of insulin required
Secondary Outcome Measures
NameTimeMethod
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 stayhypoglycemia

Trial Locations

Locations (1)

Kochi Medical School

🇯🇵

Nankoku-City, Kohasu-Okocho, Japan

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