Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
Primary Purpose
Bariatric Surgery, Carbohydrate Loading
Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Preoperative carbohydrate drink
Sponsored by
About this trial
This is an interventional treatment trial for Bariatric Surgery
Eligibility Criteria
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
Sites / Locations
- University Clinical Centre in GdanskRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Preoperative carbohydrate loaded patients
Conventional fasting protocol
Arm Description
Outcomes
Primary Outcome Measures
Glucose level
Secondary Outcome Measures
Full Information
NCT ID
NCT05692414
First Posted
January 11, 2023
Last Updated
January 11, 2023
Sponsor
Medical University of Gdansk
1. Study Identification
Unique Protocol Identification Number
NCT05692414
Brief Title
Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
Official Title
Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Gdansk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Carbohydrate Loading
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Preoperative carbohydrate loaded patients
Arm Type
Experimental
Arm Title
Conventional fasting protocol
Arm Type
No Intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Preoperative carbohydrate drink
Intervention Description
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.
Primary Outcome Measure Information:
Title
Glucose level
Time Frame
10 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University Clinical Centre in Gdansk
City
Gdańsk
State/Province
Pomeranian
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrii Bilyk
Phone
576188525
Ext
+48
Email
andrii.bilyk@gumed.edu.pl
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial
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