An interventional study of Preoperative oral carbohydrate loading and The placebo in Metabolic Syndrome (MetS), sponsored by First Affiliated Hospital of Chongqing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by First Affiliated Hospital of Chongqing Medical University · Not applicable, Interventional, and Treatment
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.
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.
2,116 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 208 is above the median of 60 across 1,572 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →First Affiliated Hospital of Chongqing Medical University is the lead sponsor of 95 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: Within 72 hours after surgery
Time to GI-3 recovery
Time frame: From the end of surgery up to 7 days after surgery.
Time to GI-2 recovery
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
Time frame: From the end of surgery up to 7 days after surgery.
Postoperative Nausea and Vomiting Score
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.
Time frame: Days 1 - 4 postoperatively
15-item Quality of Recovery Score
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.
Time frame: Days 1 - 7 and 30 postoperatively
Perioperative blood glucose levels
Time frame: Measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.
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.
Time to first postoperative flatus
Time frame: From the end of surgery up to 7 days after surgery.
Time to first postoperative defecation
Time frame: From the end of surgery up to 7 days after surgery.
Total length of hospital stay (including readmissions within 30 days after surgery)
Time frame: Within 30 days after surgery
Unplanned readmission rate within 30 days after surgery
Time frame: Within 30 days after surgery
Postoperative complications
Classified according to the Clavien-Dindo classification criteria for complications
Time frame: Within 30 days after surgery
Gastric cross-sectional area (CSA)
Calculated using the formula (AP × CC × π)/4, where AP is the anteroposterior diameter and CC is the craniocaudal diameter.
Time frame: Before anaesthetic induction
Gastric volume
= 27.0 + 14.6 × CSA - 1.28 × age
Time frame: Before anaesthetic induction
Perlas grade
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).
Time frame: Before anaesthetic induction
Corrected gastric volume (CGV)
Recalculated in mL kg-¹
Time frame: Before anaesthetic induction
Incidence of regurgitation or aspiration
Time frame: From anesthesia induction to discharge from the post-anesthesia care unit.
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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First Affiliated Hospital of Chongqing Medical University