Skip to main content
OpenTrials
Completed

NCT Number: NCT07237841

Preoperative Carbohydrate Loading in Diabetes Mellitus

This prospective, randomized, open-label, parallel-group clinical trial aims to evaluate the safety and metabolic effects of preoperative carbohydrate loading in patients with well-controlled type 2 diabetes mellitus (T2DM) undergoing elective surgery.

The study is conducted at Nhan Dan Gia Dinh Hospital (Ho Chi Minh City, Vietnam) over a 20-month period (March 2023-October 2025). Eligible participants are adults aged 18-65 years with well-controlled T2DM (HbA1c <7%, fasting plasma glucose 6.5-10 mmol/L) and no risk factors for aspiration or gastroparesis.

Participants are randomly assigned to two groups: the intervention group receives 200 mL of 25% carbohydrate solution 2 hours before anesthesia, while the control group follows standard preoperative fasting. Capillary blood glucose is measured at baseline and at 1, 2, and 4 hours after ingestion. Preoperative gastric volume is assessed by bedside ultrasonography to detect residual gastric contents.

The primary outcome is capillary blood glucose level at 4 hours after carbohydrate ingestion. Secondary outcomes include total intravenous insulin used for hyperglycemia management and the proportion of patients with gastric residual volume >1.5 mL/kg.

This study hypothesizes that preoperative carbohydrate loading in well-controlled T2DM patients increases blood glucose by no more than 2 mmol/L at 4 hours after ingestion compared to fasting, without increasing gastric residual volume or aspiration risk.

The results are expected to provide additional evidence on the safety of preoperative carbohydrate loading in diabetic patients, supporting its inclusion in Enhanced Recovery After Surgery (ERAS) protocols for optimized perioperative care.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binh Huynh

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

About this study

Preoperative carbohydrate loading has been widely recognized as a core component of Enhanced Recovery After Surgery (ERAS) protocols. In non-diabetic patients, drinking a carbohydrate solution two hours before anesthesia improves perioperative metabolic status, reduces insulin resistance, and enhances postoperative recovery without increasing the risk of aspiration or other complications. However, its safety and effectiveness in patients with type 2 diabetes mellitus (T2DM) remain controversial due to concerns about delayed gastric emptying and hyperglycemia.

Recent studies have shown that preoperative carbohydrate drinks in patients with well-controlled T2DM do not significantly delay gastric emptying and cause only transient increases in blood glucose levels, typically returning to baseline within 180 minutes. These findings suggest that carbohydrate loading may be safe for this population, provided their diabetes is well managed and they have no symptoms of gastroparesis. Despite this, current guidelines remain cautious, and further evidence is needed to strengthen clinical recommendations, particularly in Asian populations.

This randomized, open-label, parallel-group clinical trial is being conducted at Nhan Dan Gia Dinh Hospital, Ho Chi Minh City, Vietnam. The study enrolls adult patients (aged 18-65 years) with well-controlled T2DM (HbA1c <7%, fasting glucose 6.5-10 mmol/L) scheduled for elective surgery under general anesthesia. Participants are randomly assigned in a 1:1 ratio to receive either 200 mL of 25% carbohydrate solution two hours before anesthesia (intervention group) or to continue standard fasting for at least six hours before surgery (control group). Randomization is performed using computer-generated allocation.

Capillary blood glucose levels are measured at baseline and at 1, 2, and 4 hours after ingestion. Bedside gastric ultrasonography is used to estimate gastric volume before anesthesia, and residual volume greater than 1.5 mL/kg is considered gastric retention. Patients with capillary glucose >10 mmol/L persisting beyond 180 minutes will receive intravenous insulin infusion according to the hospital protocol.

The primary endpoint is capillary blood glucose level at four hours after carbohydrate ingestion. Secondary outcomes include total insulin administered to treat hyperglycemia and the proportion of participants with gastric retention before anesthesia. Safety outcomes include incidence of aspiration, diabetic ketoacidosis, and other adverse events.

The hypothesis is that preoperative carbohydrate loading in well-controlled T2DM increases blood glucose by no more than 2 mmol/L compared with fasting and does not increase gastric residual volume or aspiration risk. If confirmed, these findings will provide new evidence supporting the safe integration of carbohydrate loading into ERAS protocols for diabetic patients, helping to improve comfort, reduce perioperative stress, and optimize recovery after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18-65 years scheduled for elective surgery under general anesthesia.
  • Diagnosed with type 2 diabetes mellitus with well-controlled glycemia (HbA1c < 7% within the last 3 months).
  • Fasting plasma glucose between 6.5 and 10 mmol/L on the day before surgery.
  • ASA physical status II-III.
  • Capable of oral intake and able to provide written informed consent.
  • No contraindication to carbohydrate ingestion or ultrasonographic gastric assessment.

Exclusion criteria

  • History or clinical evidence of gastroparesis, gastroesophageal reflux disease (GERD), or hiatal hernia.
  • Conditions increasing aspiration risk: obesity (BMI > 30 kg/m²), pregnancy, or emergency surgery.
  • Severe systemic comorbidities (renal failure, hepatic failure, heart failure, or COPD exacerbation).
  • Use of medications affecting gastric motility (opioids, prokinetics, anticholinergics) within 24 hours.
  • Known hypersensitivity or intolerance to carbohydrate drink components.
  • Refusal or inability to participate.

Treatment and study plan

25% Carbohydrate solution (CHO drinking)

Dietary Supplement

Participants in the experimental arm will receive 200 mL of 25% carbohydrate solution (containing oligosaccharides) 2 hours before induction of anesthesia. The solution is consumed orally within 30 minutes.

Capillary blood glucose is measured using an ACCU-CHEK Active glucometer at baseline (before ingestion), and at 1 hour, 2 hours, and 4 hours after ingestion.

Preoperative gastric ultrasonography is performed 2 hours after ingestion in the right lateral decubitus position to estimate gastric volume and detect residual gastric content.

If blood glucose remains > 10 mmol/L for more than 180 minutes, patients will receive intravenous insulin infusion according to the hospital's protocol.

The purpose of this intervention is to evaluate the safety and metabolic impact of preoperative carbohydrate loading in well-controlled type 2 diabetes mellitus patients.

Primary outcomes

  1. Capillary blood glucose level (mmol/L) at 4 hours after carbohydrate ingestion

    Time frame: 4 hours post-ingestion

    Measured by capillary blood sample using ACCU-CHEK Active device. The endpoint tests the non-inferiority hypothesis that glucose elevation does not exceed +2 mmol/L compared to the control group.

Secondary outcomes

  1. Capillary blood glucose levels at 1 and 2 hours after ingestion

    Time frame: 1 and 2 hours post ingestion

  2. Total intravenous insulin administered for hyperglycemia (>10 mmol/L)

    Time frame: Up to 4 hours after ingestion

  3. Proportion of patients with gastric retention (GV/W >1.5 mL/kg)

    Time frame: Preoperative (2 hours after ingestion)

Sponsors and collaborators

Lead sponsor

Gia Dinh People Hospital

Other

Registry information

Official study title

Preoperative Carbohydrate Loading in Patients With Well-controlled Type 2 Diabetes Mellitus

Acronym: PRECARB-DMP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.