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Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial

Sponsor
Medical University of Gdansk (Other)
Overall Status
Recruiting
CT.gov ID
NCT05692414
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
3.9
Anticipated Duration (Months)
10.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Insulin resistance is a key feature of postoperative metabolism, leading to decreased glucose absorption in adipose tissue and skeletal muscle, with an increased glucose release due to hepatic gluconeogenesis and hyperglycemia. Development of insulin resistance is associated with increased length of hospital stay (LOS), morbidity, and mortality. One of the strategies employed to reduce the postoperative stress response and perioperative insulin resistance includes the reduction of the preoperative fasting time via preoperative carbohydrate oral (CHO) drink. Preoperative carbohydrate intake is an integral part of the Enhanced Recovery After Surgery (ERAS) protocol and previous studies have shown that preoperative carbohydrate loading can increase patient comfort. Although ERAS protocols are increasingly used and implemented in bariatric surgery centres specific components of these protocols, such as preoperative oral carbohydrate nutrition, have not yet been rigorously analyzed.

The aim of this prospective study is to compare the differences in patient outcomes between preoperative CHO loading and a conventional fasting protocol. The secondary aim is to perform a subgroup analysis of Roux-en-Y bypass and sleeve gastrectomy.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Preoperative carbohydrate drink
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Preoperative carbohydrate loaded patients

Dietary Supplement: Preoperative carbohydrate drink
Allocation will be performed using an alternating weeks scheme. Patients undergoing surgery in the first week will be included in the control group and follow a conventional fasting protocol. However, patients undergoing surgery the following week will be included in the intervention group and take 800 ml of CHO drink on the day before surgery and 400 ml on the surgery day no later than 6 hours before the procedure.
No Intervention: Conventional fasting protocol

Outcome Measures

Primary Outcome Measures

  1. Glucose level [10 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients who will undergo surgery at the Elective Surgery Clinic of the University Clinical Centre in Gdansk, Poland.
Exclusion Criteria:
  • Patients who will be unable or will refuse to express informed concern

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Clinical Centre in Gdansk Gdańsk Pomeranian Poland 80-952

Sponsors and Collaborators

  • Medical University of Gdansk

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Andrii Bilyk, Student, Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT05692414
Other Study ID Numbers:
  • NKBBN/200/2020
First Posted:
Jan 20, 2023
Last Update Posted:
Jan 20, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 20, 2023