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Effect of Preoperative Supplementation in Insulin Resistance

Primary Purpose

Liver Disease

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Aminolevan EN

Placebo

About this trial

This is an interventional health services research trial for Liver Disease focused on measuring AEN

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kochi Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient

receive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient

Outcomes

Primary Outcome Measures

to evaluate the total amount of insulin required for glycemic control after hepatic resection

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

Full Information

NCT ID

NCT00657124

First Posted

April 7, 2008

Last Updated

April 11, 2008

Sponsor

Kochi University

1. Study Identification

Unique Protocol Identification Number

NCT00657124

Brief Title

Effect of Preoperative Supplementation in Insulin Resistance

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kochi University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Disease

Keywords

AEN

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient

Arm Title

Arm Type

Placebo Comparator

Arm Description

receive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient

Intervention Type

Dietary Supplement

Intervention Name(s)

Aminolevan EN

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Other Intervention Name(s)

No receive, normal diet

Intervention Description

placebo

Primary Outcome Measure Information:

Title

to evaluate the total amount of insulin required for glycemic control after hepatic resection

Time Frame

total amount of insulin required

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Takehiro Okabayashi, MD

Organizational Affiliation

Kochi Medical School, Kochi University

Official's Role

Study Director

Facility Information:

Facility Name

Kochi Medical School

City

Nankoku-City

State/Province

Kohasu-Okocho

ZIP/Postal Code

783-8505

Country

Japan

12. IPD Sharing Statement

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Effect of Preoperative Supplementation in Insulin Resistance

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