An interventional study of Standard ERAS Fasting and Clear-Fluid Management and Oral Carbohydrate Loading in Type 2 Diabetes Mellitus (DM) and Gastrointestinal Surgery, sponsored by The Affiliated Hospital of Qingdao University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by The Affiliated Hospital of Qingdao University · Not applicable, Interventional, and Supportive care
This study is a single-center randomized controlled trial in adults with type 2 diabetes who are scheduled for elective gastrointestinal surgery. The study aims to find out whether drinking a carbohydrate-containing clear liquid before surgery can reduce early postoperative insulin resistance and improve blood glucose stability without increasing the risk of high or low blood glucose.
Participants will be randomly assigned in a 1:1:1 ratio to one of three groups. The first group will receive standard enhanced recovery after surgery (ERAS) fasting and clear-fluid management without a carbohydrate-containing drink. The second group will drink 400 mL of a 12.5% maltodextrin carbohydrate solution, providing about 50 g of carbohydrate, approximately 2 hours before anesthesia. The third group will receive 500 mL of 10% glucose solution intravenously over approximately 2 hours before anesthesia. The intravenous glucose group is included mainly to help explore whether the route of carbohydrate administration affects the metabolic response.
All participants will receive standard perioperative care. Blood glucose will be monitored during the perioperative period, including continuous glucose monitoring when available, with point-of-care blood glucose testing used to confirm clinically important high or low glucose readings and to guide treatment when necessary.
The primary outcome is insulin resistance on the first day after surgery, measured using the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), which is calculated from fasting blood glucose and fasting insulin concentrations. Secondary outcomes include perioperative glucose levels and glucose variability, time spent within, above, and below the target glucose range, insulin and C-peptide levels, postoperative nausea and vomiting, patient comfort, postoperative recovery, hospital stay, postoperative complications, and safety events such as hypoglycemia, severe hyperglycemia, reflux, or aspiration.
The main comparison of interest is between the oral carbohydrate group and the standard ERAS group. The intravenous glucose group will be analyzed mainly as a mechanistic exploratory group.
Enhanced recovery after surgery (ERAS) programs have progressively shifted perioperative fasting practice away from prolonged fasting toward shorter fasting intervals and the selective use of clear fluids before anesthesia. Preoperative oral carbohydrate loading has been proposed as a metabolic conditioning strategy that may reduce the catabolic effects of fasting, stimulate endogenous insulin secretion, suppress lipolysis, and attenuate the postoperative decline in insulin sensitivity. However, most supporting evidence has been generated in patients without diabetes.
Patients with type 2 diabetes mellitus have baseline insulin resistance, variable pancreatic beta-cell reserve, and altered responses to carbohydrate intake. Surgical stress, anesthesia, pain, and inflammatory responses may further increase hepatic glucose production and reduce peripheral glucose utilization, resulting in postoperative hyperglycemia and worsening insulin resistance. At the same time, prolonged fasting and perioperative changes in glucose-lowering therapy may increase the risks of hypoglycemia and glycemic variability. Therefore, the potential metabolic benefit of preoperative carbohydrate loading in patients with type 2 diabetes must be evaluated together with its effects on perioperative glycemic safety.
This study is designed as a single-center, prospective, three-arm, parallel-group randomized controlled trial in adults with type 2 diabetes undergoing elective gastrointestinal surgery. The trial will compare standard ERAS fasting and non-caloric clear-fluid management with preoperative oral carbohydrate loading. A third group receiving an approximately equivalent amount of glucose intravenously is included as a prespecified mechanistic exploratory comparator.
The principal clinical question is whether preoperative oral carbohydrate loading can attenuate early postoperative insulin resistance compared with standard ERAS fasting management. The primary confirmatory comparison is therefore between the oral carbohydrate group and the standard ERAS group. The intravenous glucose group is not the basis for the primary sample-size calculation and will mainly be used to explore whether any observed metabolic effect is related predominantly to glucose substrate provision or whether the oral gastrointestinal route may provide additional metabolic effects.
To reduce treatment-related heterogeneity, perioperative diabetes management will be standardized as much as clinically feasible. Non-insulin glucose-lowering agents will be discontinued before surgery according to the study protocol and current clinical safety requirements, and insulin-based perioperative glucose management will be used when necessary. Use of insulin, including timing, dose, route, and indication, will be carefully documented because exogenous insulin may influence the interpretation of fasting insulin-based measures of insulin resistance.
Continuous glucose monitoring will be used to characterize perioperative glucose patterns, while point-of-care glucose measurement will be used to confirm clinically important high or low glucose values and to guide treatment decisions. Continuous glucose monitoring data will be analyzed within prespecified perioperative time windows to describe glucose exposure, glycemic variability, and time spent within, above, or below the target glucose range.
Because delayed gastric emptying and aspiration are important concerns in patients with diabetes, individuals with known or suspected gastroparesis, gastric outlet obstruction, upper gastrointestinal obstruction, or other conditions associated with high aspiration risk will be excluded. Gastric antral ultrasonography will be performed before anesthesia as an additional exploratory assessment of gastric contents and aspiration-related safety.
The primary metabolic assessment will focus on insulin resistance on the first postoperative day. Additional metabolic measurements will include glucose, insulin, C-peptide, and selected markers of lipid metabolism, ketone production, and surgical stress. Repeated postoperative measurements will allow evaluation of the early postoperative metabolic trajectory. Perioperative glucose control, patient comfort, postoperative nausea and vomiting, recovery variables, length of hospital stay, postoperative complications, and predefined safety events will also be assessed.
Randomization will be performed in a 1:1:1 ratio using a variable-block randomization sequence with allocation concealment. Because the interventions are visibly different, participants and the personnel administering the interventions cannot be blinded. However, laboratory personnel, outcome assessors, gastric ultrasound assessors, and statistical analysts will remain blinded to treatment allocation whenever feasible.
The study will follow the intention-to-treat principle for the primary analysis. The primary confirmatory analysis will estimate the difference in postoperative day 1 insulin resistance between the oral carbohydrate and standard ERAS groups with prespecified adjustment for clinically relevant baseline covariates. Comparisons involving the intravenous glucose group will be interpreted as mechanistic and exploratory.
This trial is intended to provide clinically relevant evidence regarding the metabolic effectiveness and perioperative safety of preoperative oral carbohydrate loading in carefully selected patients with type 2 diabetes undergoing gastrointestinal surgery, and to help define an evidence-based approach to carbohydrate administration within ERAS pathways for this population.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 126 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →The Affiliated Hospital of Qingdao University is the lead sponsor of 149 studies on the registry; 56 are open to participants now.
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1.Age 18 to 75 years, regardless of sex. 2.Diagnosis of type 2 diabetes mellitus. 3. (HbA1c) ≤8.0%, with preoperative fasting plasma glucose generally ≤10.0 mmol/L.
4.Scheduled to undergo elective gastrointestinal surgery. 5.Able to wear a continuous glucose monitoring (CGM) device for at least 24 hours before surgery and willing to continue monitoring until hospital discharge or the protocol-specified time point.
6.Able to understand the study procedures, voluntarily participate in the study, and provide written .
Exclusion Criteria:
1. Known or highly suspected diabetic gastroparesis, delayed gastric emptying, gastric outlet obstruction, or upper gastrointestinal obstruction.
2. Severe gastroesophageal reflux disease or other conditions considered by the investigator to confer a high risk of aspiration.
3. Emergency surgery or other non-elective surgery for which the study intervention cannot be implemented as planned.
4. Type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.
5. Pregnancy or breastfeeding. 6. Recent systemic therapy. 7. Severe hepatic or renal dysfunction, or active severe infection. 8. Inability to comply with CGM use, cognitive or psychiatric conditions preventing completion of study assessments, or anticipated poor adherence to the study protocol.
9. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
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.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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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.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive standard ERAS preoperative fasting and non-caloric clear-fluid management without a carbohydrate-containing drink.
Other: Standard ERAS Fasting and Clear-Fluid Management
Participants will receive 400 mL of a 12.5% maltodextrin solution containing approximately 50 g of carbohydrate before anesthesia.
Dietary Supplement: Oral Carbohydrate Loading
Participants will receive 500 mL of 10% glucose solution containing approximately 50 g of glucose intravenously before anesthesia.
Drug: Intravenous Glucose
Participants will follow the institutional ERAS preoperative fasting protocol, including cessation of solid food at least 6 hours before anesthesia and allowance of non-caloric clear fluids according to the assigned study protocol. No carbohydrate-containing beverage will be administered before surgery.
Participants will receive 400 mL of a 12.5% maltodextrin solution containing approximately 50 g of carbohydrate, administered orally approximately 2 hours before induction of anesthesia.
Participants will receive 500 mL of 10% glucose solution containing approximately 50 g of glucose, administered intravenously over approximately 2 hours before induction of anesthesia.
Postoperative Day 1 Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR will be calculated using fasting plasma glucose and fasting serum insulin measured on the morning of postoperative day 1. HOMA-IR will be calculated as fasting plasma glucose (mmol/L) × fasting insulin (μU/mL) / 22.5. Higher values indicate greater insulin resistance.
Time frame: Postoperative day 1
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