NCT07237841Completed
Preoperative Carbohydrate Loading in Diabetes Mellitus
Preoperative Carbohydrate Loading in Patients With Well-controlled Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 15 Nov 2025
- Start date
- 1 Mar 2023
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Gia Dinh People Hospital
- Diseases
- Type 2 diabetes
- NCT number
- NCT07237841
What you commit to
- Study type: Interventional
- Participants enrolled: 76
- From 1 Mar 2023 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of medications affecting gastric motility (opioids, prokinetics, anticholinergics) within 24 hours.
Other illness
- 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).
- Known hypersensitivity or intolerance to carbohydrate drink components.
Other
- Refusal or inability to participate.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Binh Huynh Coordinator of this site? Confirm its status | Ho Chi Minh City | Vietnam | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.