Preoperative Carbohydrate Loading in Bariatric Surgery

Phase 4

• Conditions: Obesity, Morbid
• Interventions: Dietary Supplement: Nutricia PreOp

• Registration Number: NCT04486079
• Lead Sponsor: Medical University of Gdansk

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-12
• Study Start: 2020-07-20
• Study First Submitted QC: 2020-07-21
• Last Update Submitted: 2020-07-21
• Study First Posted: 2020-07-24
• Last Update Posted: 2020-07-24
• Primary Completion: 2021-07-20
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Carbohyrate loading	Nutricia PreOp	Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group.

Primary Outcome Measures

Name	Time	Method
QoR40 score	1st postoperatie day	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk; 🇵🇱 Gdańsk, Pomerania, Poland