Preoperative Oral Carbohydrate Loading in Patients With Type 2 Diabetes Undergoing Gastrointestinal Surgery

NCT07830537 | Not Yet Recruiting

• 1 other identifier: QDAH-T2DM
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus (DM); Gastrointestinal Surgery

Keywords

Preoperative Carbohydrate Loading; Type 2 Diabetes Mellitus; Gastrointestinal Surgery; Enhanced Recovery After Surgery; HOMA-IR; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• 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.

  Postoperative day 1

Study Arms (3)

Standard ERAS Group

OTHER

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

Oral Carbohydrate Group

EXPERIMENTAL

Participants will receive 400 mL of a 12.5% maltodextrin solution containing approximately 50 g of carbohydrate before anesthesia.

Dietary Supplement: Oral Carbohydrate Loading

Intravenous Glucose Group

EXPERIMENTAL

Participants will receive 500 mL of 10% glucose solution containing approximately 50 g of glucose intravenously before anesthesia.

Drug: Intravenous Glucose

Interventions

Standard ERAS Fasting and Clear-Fluid Management OTHER

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.

Standard ERAS Group

Oral Carbohydrate Loading DIETARY_SUPPLEMENT

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.

Oral Carbohydrate Group

Intravenous Glucose DRUG

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.

Intravenous Glucose Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years, regardless of sex. 2.Diagnosis of type 2 diabetes mellitus. 3.Glycated hemoglobin (HbA1c) ≤8.0%, with preoperative fasting plasma glucose generally ≤10.0 mmol/L.
• 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.
• Able to understand the study procedures, voluntarily participate in the study, and provide written informed consent.

You may not qualify if:

• \. Known or highly suspected diabetic gastroparesis, delayed gastric emptying, gastric outlet obstruction, or upper gastrointestinal obstruction.
• \. Severe gastroesophageal reflux disease or other conditions considered by the investigator to confer a high risk of aspiration.
• \. Emergency surgery or other non-elective surgery for which the study intervention cannot be implemented as planned.
• \. Type 1 diabetes mellitus, gestational diabetes mellitus, or other specific types of diabetes.
• \. Pregnancy or breastfeeding. 6. Recent systemic glucocorticoid 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.
• \. Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Diet, Carbohydrate Loading; Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Surgery, Professor and Chief Physician

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 21, 2026

Record last verified: 2026-09