Preoperative Carbohydrate Loading in Diabetes Mellitus

Summary

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.

Conditions

• Type2diabetes
• Enhanced Recovery After Surgery (ERAS)
• Fasting
• Carbohydrate Loading
• Gastric Emptying

Interventions

DIETARY_SUPPLEMENT

25% Carbohydrate solution (CHO drinking)

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.

Sponsors & Collaborators

• Gia Dinh People Hospital

  lead OTHER

Principal Investigators

• Huynh Van Binh · Nhan dan Gia Dinh Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-03-01

Primary Completion

2025-06-30

Completion

2025-09-30

Countries

• Vietnam

Study Locations