Last reviewed · How we verify
Preoperative Carbohydrate Loading in Diabetes Mellitus (PRECARB-DMP)
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.
Details
| Lead sponsor | Gia Dinh People Hospital |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 76 |
| Start date | Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Sep 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Type2diabetes
- Enhanced Recovery After Surgery (ERAS)
- Fasting
- Carbohydrate Loading
- Gastric Emptying
Interventions
- 25% Carbohydrate solution (CHO drinking)
Countries
Vietnam