Preoperative Carbohydrate Loading in Diabetes Mellitus

NCT07237841 | Completed DMC

• 1 other identifier: 50/NDGĐ-HĐĐĐ
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Carbohydrate loading; Preoperative care; Gastric residual; Fasting; ERAS

Outcome Measures

Primary Outcomes (1)

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

  4 hours post-ingestion

Secondary Outcomes (3)

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

  1 and 2 hours post ingestion

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

  Up to 4 hours after ingestion

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

  Preoperative (2 hours after ingestion)

Study Arms (2)

Standard fasting group

NO INTERVENTION

Participants fast for at least six hours before anesthesia, following standard preoperative fasting guidelines. Capillary blood glucose is measured at baseline, and at 1, 2, and 4 hours before surgery.

Carbohydrate loading group (25% carbohydrate solution)

EXPERIMENTAL

Participants receive 200 mL of 25% carbohydrate solution two hours before anesthesia. Capillary blood glucose is measured at baseline, and at 1, 2, and 4 hours after ingestion. Preoperative gastric ultrasonography is performed 2 hours after ingestion to assess residual gastric volume.

Dietary Supplement: 25% Carbohydrate solution (CHO drinking)

Interventions

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.

Carbohydrate loading group (25% carbohydrate solution)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gia Dinh People Hospital: lead

Study Sites (1)

Binh Huynh

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

Location

Related Publications (1)

• Gustafsson UO, Nygren J, Thorell A, Soop M, Hellstrom PM, Ljungqvist O, Hagstrom-Toft E. Pre-operative carbohydrate loading may be used in type 2 diabetes patients. Acta Anaesthesiol Scand. 2008 Aug;52(7):946-51. doi: 10.1111/j.1399-6576.2008.01599.x. Epub 2008 Mar 7.

  PMID: 18331374 BACKGROUND

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Huynh Van Binh

  Nhan dan Gia Dinh Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two groups: interventional group and controlled group.

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 20, 2025
• Study Start: March 1, 2023
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)