Effect of Preoperative Supplementation in Insulin Resistance

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Liver Disease

Intervention / Treatment
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* Dietary Supplement: Aminolevan EN
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>receive a preoperative supplementation with carbohydrate and branched-chain amino acids-enriched nutrient | Dietary Supplement: Aminolevan EN<br>* 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.<br>|
| Placebo Comparator: 2<br>receive a preoperative supplementation without carbohydrate and branched-chain amino acids-enriched nutrient | Dietary Supplement: Placebo<br>* placebo<br>* Other names: No receive, normal diet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the total amount of insulin required for glycemic control after hepatic resection |  | total amount of insulin required | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AEN