We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Preoperative Supplementation in Insulin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00657124
First Posted: April 14, 2008
Last Update Posted: April 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kochi University
  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
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

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 ]

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 ]

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.
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kochi Medical School, Kochi University
ClinicalTrials.gov Identifier: NCT00657124     History of Changes
Other Study ID Numbers: PEA-AP-01
Kochi University
First Submitted: April 7, 2008
First Posted: April 14, 2008
Last Update Posted: April 14, 2008
Last Verified: April 2008

Keywords provided by Kochi University:
AEN

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