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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated Hospital of Qingdao University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1.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.

Disqualifiers

1. Known or highly suspected diabetic gastroparesis, delayed gastric emptying, gastric outlet obstruction, or upper gastrointestinal obstruction.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard ERAS Fasting and Clear-Fluid Management

    Other intervention

    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.

  • 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.

  • 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.

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: Standard ERAS GroupOther 1 intervention
Group B: Oral Carbohydrate GroupExperimental treatment 1 intervention
Group C: Intravenous Glucose GroupExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Postoperative day 1

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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