Preoperative Carbohydrate Loading in Bariatric Surgery

Study Overview
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Brief Summary
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The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance

Official Title
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Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail

Conditions
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Obesity, Morbid

Intervention / Treatment
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* Dietary Supplement: Nutricia PreOp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Obtaining written and informed patient consent. No medical contraindications to perform a bariatric operation No contraindications for the use of a rich carbohydrate drink Exclusion Criteria: No consent to participate in the study Age under 18 years The intolerance of the carbohydrate drink used in the test The contraindications to perform bioimpedance measurements of body composition

Ages Eligible for Study
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Minimum Age: 18 Years

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carbohyrate loading<br>Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group. | Dietary Supplement: Nutricia PreOp<br>* A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.<br>|
| No Intervention: Fasting<br>Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoR40 score | Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery) | 1st postoperatie day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HOMA-IR | changes in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance) | first assay one month before the operation, the second assay on the first postoperative day | 
| Body composition | changes in body composition will be assessed by electric bioimpedance method | first assay one month before the operation, the second assay on the first postoperative day | 
| Length of hospital stay | length of stay record in hours | From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, carbohydrate loading, insulin resistance