Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial

Bariatric Surgery Clinical Trial

Official title:

Preoperative Carbohydrate Loading in Bariatric Surgery - Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692414
• Other study ID #: NKBBN/200/2020
• Status: Recruiting
• Phase: N/A
• Start date: January 2023
• Est. completion date: May 2023

Study information

• Verified date: January 2023
• Source: Medical University of Gdansk
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery

Intervention

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.

Locations

Country	Name	City	State
Poland	University Clinical Centre in Gdansk	Gdansk	Pomeranian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose level		10 days