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NCT Number: NCT07822763

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Chongqing, Chongqing Municipality, 400016, China

Location contact

Ren Li, PhD

CONTACT

[email protected]

8618323187421

About this study

This prospective, randomized trial aims to evaluate the efficacy and safety of preoperative oral carbohydrate loading for postoperative gastrointestinal recovery in patients with metabolic syndrome undergoing bariatric surgery. Eligible participants will be randomly assigned in a 1:1 ratio to either the preoperative oral carbohydrate loading group or the placebo group.

Participants in both groups will follow a standardized preoperative fasting protocol, with solid food prohibited for at least 6 hours before induction of anesthesia and clear liquids discontinued 2 hours before surgery. Participants in the POC group will consume 400 mL of an oral carbohydrate-containing beverage 2 hours before surgery, whereas participants in the control group will consume an equal volume of a placebo beverage with a similar appearance and taste but containing no carbohydrates at the same time point.

The primary outcome is postoperative gastrointestinal functional recovery, assessed using the GI-3 criteria. GI-3 recovery is defined as tolerance of oral intake accompanied by recovery of lower gastrointestinal function. The study will evaluate both the proportion of participants achieving GI-3 recovery within the predefined postoperative period and the time to GI-3 recovery.

Secondary outcomes include other measures related to postoperative gastrointestinal recovery, postoperative nausea and vomiting, quality of recovery, length of hospital stay, and other postoperative recovery-related outcomes. Perioperative blood glucose levels and glycemic variability will be assessed to evaluate the metabolic safety of preoperative oral carbohydrate loading.

Safety outcomes related to preoperative oral carbohydrate intake will also be assessed. Gastric ultrasonography will be performed before induction of anesthesia to evaluate gastric volume, corrected gastric volume, gastric antral cross-sectional area, and Perlas grade. The occurrence of perioperative regurgitation or pulmonary aspiration will also be recorded.

This study aims to determine whether, compared with placebo, preoperative oral carbohydrate loading can enhance postoperative gastrointestinal recovery in patients with metabolic syndrome undergoing bariatric surgery without increasing clinically significant perioperative glycemic fluctuations or aspiration-related risks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. GI-3 recovery rate within 72 hours after surgery

    Time frame: 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.

Secondary outcomes

  1. Time to GI-3 recovery

    Time frame: From the end of surgery up to 7 days after surgery.

  2. Time to GI-2 recovery

    Time frame: From the end of surgery up to 7 days after surgery.

    GI-2 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 defecation

  3. Postoperative Nausea and Vomiting Score

    Time frame: Days 1 - 4 postoperatively

    Postoperative nausea and vomiting were assessed using the Postoperative Nausea and Vomiting Score, ranging from 0 to 6, with higher scores indicating more severe postoperative nausea and vomiting.

  4. 15-item Quality of Recovery Score

    Time frame: Days 1 - 7 and 30 postoperatively

    Quality of recovery was assessed using the 15-item Quality of Recovery Score, ranging from 0 to 150, with higher scores indicating better postoperative recovery.

  5. Perioperative blood glucose levels

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

  6. Glycemic variability

    Time frame: Calculated based on blood glucose levels measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.

  7. Time to first postoperative flatus

    Time frame: From the end of surgery up to 7 days after surgery.

  8. Time to first postoperative defecation

    Time frame: From the end of surgery up to 7 days after surgery.

  9. Total length of hospital stay (including readmissions within 30 days after surgery)

    Time frame: Within 30 days after surgery

Other outcomes

  1. Unplanned readmission rate within 30 days after surgery

    Time frame: Within 30 days after surgery

  2. Postoperative complications

    Time frame: Within 30 days after surgery

    Classified according to the Clavien-Dindo classification criteria for complications

  3. Gastric cross-sectional area (CSA)

    Time frame: Before anaesthetic induction

    Calculated using the formula (AP × CC × π)/4, where AP is the anteroposterior diameter and CC is the craniocaudal diameter.

  4. Gastric volume

    Time frame: Before anaesthetic induction

    = 27.0 + 14.6 × CSA - 1.28 × age

  5. Perlas grade

    Time frame: Before anaesthetic induction

    Graded according to the Perlas system: grade 0 (no content in either position), grade 1 (only a small amount of fluid visible in the right lateral decubitus position), and grade 2 (distended antrum with fluid visible in both positions).

  6. Corrected gastric volume (CGV)

    Time frame: Before anaesthetic induction

    Recalculated in mL kg-¹

  7. Incidence of regurgitation or aspiration

    Time frame: From anesthesia induction to discharge from the post-anesthesia care unit.

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Ke, PhD

CONTACT

[email protected]

+86 13883904332

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital of Chongqing Medical University

Other

Registry information

Official study title

Preoperative Oral Carbohydrate Loading for Enhanced Gastrointestinal Recovery After Bariatric Surgery in Patients With Metabolic Syndrome

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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