Study Results
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Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2023-03-01
2025-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard fasting group
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.
No interventions assigned to this group
Carbohydrate loading group (25% carbohydrate solution)
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Gia Dinh People Hospital
OTHER
Responsible Party
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Principal Investigators
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Huynh Van Binh
Role: STUDY_DIRECTOR
Nhan dan Gia Dinh Hospital
Locations
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Binh Huynh
Ho Chi Minh City, Ho Chi Minh, Vietnam
Countries
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References
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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.
Other Identifiers
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50/NDGĐ-HĐĐĐ
Identifier Type: -
Identifier Source: org_study_id
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