NCT04486079

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2020

Completed
8 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

July 24, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

July 12, 2020

Last Update Submit

July 21, 2020

Conditions

Obesity, Morbid

Keywords

bariatric surgerycarbohydrate loadinginsulin resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • HOMA-IR

    first assay one month before the operation, the second assay on the first postoperative day

  • Body composition

    first assay one month before the operation, the second assay on the first postoperative day

  • 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

Study Arms (2)

Carbohyrate loading

EXPERIMENTAL

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

Fasting

NO INTERVENTION

Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard.

Interventions

Nutricia PreOpDIETARY_SUPPLEMENT

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.

Carbohyrate loading

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Obtaining written and informed patient consent.
  • No medical contraindications to perform a bariatric operation
  • No contraindications for the use of a rich carbohydrate drink

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, 80-214, Poland

RECRUITING

Related Publications (4)

  • Knight P, Chou J, Dusseljee M, Verseman S, Elian A. Effective reduction in stress induced postoperative hyperglycemia in bariatric surgery by better carb loading. Am J Surg. 2020 Mar;219(3):396-398. doi: 10.1016/j.amjsurg.2019.10.042. Epub 2019 Nov 9.

    PMID: 31757437RESULT

  • Grant MC, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, McEvoy MD, King AB, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Bariatric Surgery. Anesth Analg. 2019 Jul;129(1):51-60. doi: 10.1213/ANE.0000000000003696.

    PMID: 30113392RESULT

  • Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21.

    PMID: 28000931RESULT

  • Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3.

    PMID: 26943657RESULT

MeSH Terms

Conditions

Obesity, MorbidInsulin Resistance

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Maciej Wilczyński

    General Surgery Resident, PhD Fellow, Teaching Assistant

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maciej Wilczyński

CONTACT

603383368mwilczynski@gumed.edu.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2020

First Posted

July 24, 2020

Study Start

July 20, 2020

Primary Completion

July 20, 2021

Study Completion

October 31, 2021

Last Updated

July 24, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Medical University of Gdańsk will be the owner of data

Locations

PL(1)