Preoperative Oral Carbohydrate Loading and Gastrointestinal Recovery After Bariatric Surgery in Metabolic Syndrome

NCT07822763 | Not Yet Recruiting DMC

• 1 other identifier: POC-MetS-2026-01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled trial aims to evaluate the effect of preoperative oral carbohydrate loading on postoperative gastrointestinal recovery in patients with metabolic syndrome undergoing bariatric surgery. Eligible participants will be randomly assigned to either a preoperative oral carbohydrate drink group or a standard preoperative fasting group. The primary objective of this study is to determine whether preoperative oral carbohydrate loading can facilitate early postoperative gastrointestinal recovery. Outcome measures will include the proportion of patients achieving postoperative gastrointestinal recovery, time to postoperative gastrointestinal recovery, perioperative blood glucose levels, and other postoperative recovery-related outcomes. This study aims to provide clinical evidence regarding the efficacy and safety of preoperative oral carbohydrate loading in patients with metabolic syndrome undergoing bariatric surgery.

Conditions

Metabolic Syndrome (MetS)

Keywords

Preoperative oral carbohydrate; Metabolic Syndrome; Bariatric surgery; Gastrointestinal recovery

Outcome Measures

Primary Outcomes (1)

• GI-3 recovery rate within 72 hours after surgery

  GI-3 is a composite endpoint defined as the ability to tolerate oral intake (consumption of food and drink at three consecutive meals without significant nausea or vomiting), accompanied by flatus or defecation.

  Within 72 hours after surgery

Secondary Outcomes (9)

• Time to GI-3 recovery

  From the end of surgery up to 7 days after surgery.

• Time to GI-2 recovery

  From the end of surgery up to 7 days after surgery.

• Postoperative Nausea and Vomiting Score

  Days 1 - 4 postoperatively

• 15-item Quality of Recovery Score

  Days 1 - 7 and 30 postoperatively

• Perioperative blood glucose levels

  Measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.

Other Outcomes (7)

• Unplanned readmission rate within 30 days after surgery

  Within 30 days after surgery

• Postoperative complications

  Within 30 days after surgery

• Gastric cross-sectional area (CSA)

  Before anaesthetic induction

Study Arms (2)

POC Group

EXPERIMENTAL

Fasted from solid foods for ≥6 hours (≥8 hours after fatty or meat-containing meals), with clear liquids permitted until 2 hours before surgery, and consumed 400 mL of a carbohydrate-containing clear liquid 2 hours before surgery.

Other: Preoperative oral carbohydrate loading

Control Group

PLACEBO COMPARATOR

Fasted from solid foods for ≥6 hours (≥8 hours after fatty or meat-containing meals), with clear liquids permitted until 2 hours before surgery, and consumed 400 mL of a non-caloric, carbohydrate-free clear liquid with a similar appearance and taste 2 hours before surgery.

Other: The placebo

Interventions

Preoperative oral carbohydrate loading OTHER

Participants in the POC group were fasted from solid foods for ≥6 hours (≥8 hours after fatty or meat-containing meals), with clear liquids permitted until 2 hours before surgery, and consumed 400 mL of a carbohydrate-containing clear liquid 2 hours before surgery. The beverage provided 12.5 g of carbohydrates per 100 mL and contained no fiber, protein, or fat.

POC Group

The placebo OTHER

Participants in the placebo group were instructed to follow the same preoperative fasting regimen and to consume 400 mL of a matching non-caloric, carbohydrate-free clear liquid 2 hours before surgery. The placebo was similar to the carbohydrate-containing beverage in appearance and taste，but contained no carbohydrates, fiber, protein, or fat.

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults aged 18-65 years;
• diagnosis of metabolic syndrome (≥3 of the following: elevated waist circumference, elevated triglycerides, elevated blood pressure, elevated fasting glucose, and reduced HDL-C);
• eligibility for bariatric surgery(body mass index ≥35 kg/m² or metabolic disease with body mass index 27.5-34.9 kg/m²), with planned Roux-en-Y gastric bypass or sleeve gastrectomy;
• provision of written informed consent and willingness to complete follow-up.

You may not qualify if:

• gastrointestinal motility disorders;
• severe cardiovascular, pulmonary, hepatic, or renal dysfunction;
• HbA1c ≥8.0%;
• fasting plasma glucose \>10.0 mmol/L at the preoperative assessment;
• malnutrition;
• known allergy to carbohydrate preparations;
• pregnancy or lactation;
• previous bariatric or gastrointestinal surgery;
• chronic use of medications known to substantially affect gastrointestinal motility.

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University（No. 1 Youyi Road, Yuzhong District, Chongqing 400016, China）

Chongqing, Chongqing Municipality, 400016, China

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Wei Ke, PhD

  First Affiliated Hospital of Chongqing Medical University

  STUDY DIRECTOR

Central Study Contacts

Wei Ke, PhD

CONTACT

+86 13883904332; wk202448@hospital-cqmu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participant, treating anesthesiologist and surgical team, and outcomes assessor will be blinded to prevent bias. One of the study team co-investigators who is not the treating anesthesiologist during the participants's surgery will prepare the carbohydrate drink and the placebo。
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Department of Anesthesiology

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the POC group receiving 400 mL of a carbohydrate-containing clear liquid 2 hours before surgery, or the placebo group receiving 400 mL of a matching non-caloric, carbohydrate-free clear liquid. Each participant will receive only one type of intervention. The study is designed as a parallel, double-blind, randomized controlled trial.

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 16, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)