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Preoperative Carbohydrate Loading in Bariatric Surgery

Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04486079
Enrollment
400
Registered
2020-07-24
Start date
2020-07-20
Completion date
2021-10-31
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

bariatric surgery, carbohydrate loading, insulin resistance

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

Interventions

DIETARY_SUPPLEMENTNutricia PreOp

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.

Sponsors

Medical University of Gdansk
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
QoR40 score1st postoperatie dayQuality 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

MeasureTime frameDescription
HOMA-IRfirst assay one month before the operation, the second assay on the first postoperative daychanges in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance)
Body compositionfirst assay one month before the operation, the second assay on the first postoperative daychanges in body composition will be assessed by electric bioimpedance method
Length of hospital stayFrom the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 dayslength of stay record in hours

Countries

Poland

Contacts

Primary ContactMaciej Wilczyński
mwilczynski@gumed.edu.pl603383368

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026