Metabolic Syndrome (MetS)
Conditions
Keywords
Preoperative oral carbohydrate, Metabolic Syndrome, Bariatric surgery, Gastrointestinal recovery
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.
Detailed description
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.
Interventions
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.
OTHERThe placebo
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.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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。
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. adults aged 18-65 years; 2. diagnosis of metabolic syndrome (≥3 of the following: elevated waist circumference, elevated triglycerides, elevated blood pressure, elevated fasting glucose, and reduced HDL-C); 3. 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; 4. provision of written informed consent and willingness to complete follow-up.
Exclusion criteria
1. gastrointestinal motility disorders; 2. severe cardiovascular, pulmonary, hepatic, or renal dysfunction; 3. HbA1c ≥8.0%; 4. fasting plasma glucose \>10.0 mmol/L at the preoperative assessment; 5. malnutrition; 6. known allergy to carbohydrate preparations; 7. pregnancy or lactation; 8. previous bariatric or gastrointestinal surgery; 9. chronic use of medications known to substantially affect gastrointestinal motility.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GI-3 recovery rate within 72 hours after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 |
| Postoperative Nausea and Vomiting Score | 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. |
| 15-item Quality of Recovery Score | 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. |
| Perioperative blood glucose levels | Measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery. | — |
| Glycemic variability | 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 | From the end of surgery up to 7 days after surgery. | — |
| Time to first postoperative defecation | From the end of surgery up to 7 days after surgery. | — |
| Total length of hospital stay (including readmissions within 30 days after surgery) | Within 30 days after surgery | — |
Countries
China
Contacts
CONTACTWei Ke, PhD
STUDY_DIRECTORWei Ke, PhD
First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed