Metabolic Syndrome (MetS)NCT07822763
Preoperative Oral Carbohydrate Loading and Gastrointestinal Recovery After Bariatric Surgery in Metabolic Syndrome
A study testing Preoperative oral carbohydrate loading in people with Metabolic Syndrome (MetS), run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome (MetS)
- What is being tested?
- Preoperative oral carbohydrate loading
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2026to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- pregnancy or lactation;
- previous bariatric or gastrointestinal surgery;
- chronic use of medications known to substantially affect gastrointestinal motility.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University（No. 1 Youyi Road, Yuzhong District, Chongqing 400016, China）
Chongqing, Chongqing Municipality, 400016
Ren Li, PhD, 8618323187421, renli177@163.com
About this study
Official title: Preoperative Oral Carbohydrate Loading for Enhanced Gastrointestinal Recovery After Bariatric Surgery in Patients With 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.
Read the 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.
- Conditions
- Metabolic Syndrome (MetS)
- Being tested
- Preoperative oral carbohydrate loading, The placebo
- Keywords
- Preoperative oral carbohydrate, Metabolic Syndrome, Bariatric surgery, Gastrointestinal recovery
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative oral carbohydrate loadingOther
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 placeboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: The placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 72 hours after surgery
Secondary outcomes (9)
Time to GI-3 recovery
Measured: 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
Measured: 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.
Measured: 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.
Measured: Days 1 - 7 and 30 postoperatively
Perioperative blood glucose levels
Measured: Measured before anesthesia induction, 1 hour after incision, before leaving the operating room, and 1 hour after surgery.
Glycemic variability
Measured: 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
Measured: From the end of surgery up to 7 days after surgery.
Time to first postoperative defecation
Measured: From the end of surgery up to 7 days after surgery.
Total length of hospital stay (including readmissions within 30 days after surgery)
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start8 Oct 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Syndrome (MetS)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Chongqing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tong Mu, First Affiliated Hospital of Chongqing Medical University
- Investigators
- Wei Ke, PhD, Study director, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822763
- Sponsor's protocol ID
- POC-MetS-2026-01
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Oral Carbohydrate Loading for Enhanced Gastrointestinal Recovery After Bariatric Surgery in Patients With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT07822763
- Acronym / sponsor ID
- POC-MetS-2026-01
- Conditions
- Metabolic Syndrome (MetS)
- Keywords
- Preoperative oral carbohydrate, Metabolic Syndrome, Bariatric surgery, Gastrointestinal recovery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 8 Oct 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 16 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| POC Group | Experimental | Other: Preoperative oral carbohydrate loadingFasted 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. |
| Control Group | Placebo comparator | Other: The placeboFasted 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative oral carbohydrate loadingParticipants 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. | Other | POC Group |
| The placeboParticipants 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. | Other | Control Group |
Primary outcome
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.
9 secondary outcomes
Time to GI-3 recovery
Time frame: From the end of surgery up to 7 days after surgery.
Time to GI-2 recovery
Time frame: From the end of surgery up to 7 days after surgery.
Postoperative Nausea and Vomiting Score
Time frame: Days 1 - 4 postoperatively
15-item Quality of Recovery Score
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Ke, PhD study director
First Affiliated Hospital of Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative oral carbohydrate loading in people with Metabolic Syndrome (MetS), run by First Affiliated Hospital of Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Ke, PhD (+86 13883904332, wk202448@hospital-cqmu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GI-3 recovery rate within 72 hours after surgery (time frame: Within 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.