Effect of Preoperative Supplementation in Insulin Resistance

This study has been completed.
Sponsor:
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT00657124
First received: April 7, 2008
Last updated: April 11, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Liver Disease
Dietary Supplement: Aminolevan EN
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Kochi University:

Primary Outcome Measures:
  • to evaluate the total amount of insulin required for glycemic control after hepatic resection [ Time Frame: total amount of insulin required ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: April 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Aminolevan EN
Placebo Comparator: 2
receive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient
Dietary Supplement: Placebo
placebo
Other Name: No receive, normal diet

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00657124

Locations
Japan
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
  More Information

No publications provided

Responsible Party: Kochi Medical School, Kochi University
ClinicalTrials.gov Identifier: NCT00657124     History of Changes
Other Study ID Numbers: PEA-AP-01, Kochi University
Study First Received: April 7, 2008
Last Updated: April 11, 2008
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kochi University:
AEN

Additional relevant MeSH terms:
Insulin Resistance
Liver Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 19, 2014