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Completed

NCT Number: NCT00657124

Effect of Preoperative Supplementation in Insulin Resistance

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.

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Key information

Conditions

Liver Disease Digestive System Diseases Liver Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kochi Medical School

Nankoku, Kohasu-Okocho, 783-8505, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aminolevan EN

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.

Placebo

Dietary Supplement

placebo

Other names: No receive, normal diet

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

Sponsors and collaborators

Lead sponsor

Kochi University

Other

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 14, 2008
Registry last updated
Apr 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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