Effect of Preoperative Supplementation in Insulin Resistance

Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00657124
• Other study ID #: PEA-AP-01
• Secondary ID: Kochi University
• Status: Completed
• Phase: Phase 4
• First received: April 7, 2008
• Last updated: April 11, 2008
• Start date: April 2007
• Est. completion date: December 2007

Study information

• Verified date: April 2008
• Source: Kochi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Education, Culture, Sports, Science and Technology
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Insulin Resistance
• Liver Disease
• Liver Diseases

Intervention

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
placebo

Locations

Country	Name	City	State
Japan	Kochi Medical School	Nankoku-City	Kohasu-Okocho

Sponsors (1)

Lead Sponsor	Collaborator
Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to evaluate the total amount of insulin required for glycemic control after hepatic resection		total amount of insulin required	Yes
Secondary	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	Yes