Effect of Preoperative Supplementation in Insulin Resistance
This study has been completed.
Sponsor:
Kochi University
Information provided by:
Kochi University
ClinicalTrials.gov Identifier:
NCT00657124
First received: April 7, 2008
Last updated: April 11, 2008
Last verified: April 2008
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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 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 June 18, 2013