Type2diabetesPRECARB-DMPNCT07237841
Preoperative Carbohydrate Loading in Diabetes Mellitus
A study testing 25% Carbohydrate solution (CHO drinking) in people with Type2diabetes and Enhanced Recovery After Surgery (ERAS), run by Gia Dinh People Hospital at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2diabetes, Enhanced Recovery After Surgery (ERAS), Fasting
- What is being tested?
- 25% Carbohydrate solution (CHO drinking)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Mar 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Carbohydrate Loading in Patients With Well-controlled Type 2 Diabetes Mellitus
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.
Read more
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.
Read the detailed description
Preoperative carbohydrate loading has been widely recognized as a core component of Enhanced Recovery After Surgery (ERAS) protocols. In non-diabetic patients, drinking a carbohydrate solution two hours before anesthesia improves perioperative metabolic status, reduces insulin resistance, and enhances postoperative recovery without increasing the risk of aspiration or other complications. However, its safety and effectiveness in patients with type 2 diabetes mellitus (T2DM) remain controversial due to concerns about delayed gastric emptying and hyperglycemia.
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
- Type2diabetes, Enhanced Recovery After Surgery (ERAS), Fasting, Carbohydrate Loading, Gastric Emptying
- Being tested
- 25% Carbohydrate solution (CHO drinking)
- Keywords
- Carbohydrate loading, Preoperative care, Gastric residual, Fasting, ERAS
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: 25% Carbohydrate solution (CHO drinking) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 hours post-ingestion
Secondary outcomes (3)
Capillary blood glucose levels at 1 and 2 hours after ingestion
Measured: 1 and 2 hours post ingestion
Total intravenous insulin administered for hyperglycemia (>10 mmol/L)
Measured: Up to 4 hours after ingestion
Proportion of patients with gastric retention (GV/W >1.5 mL/kg)
Measured: Preoperative (2 hours after ingestion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start1 Mar 2023
- Primary completion30 Jun 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two groups: interventional group and controlled group.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gia Dinh People Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huynh Van Binh, Study director, Nhan dan Gia Dinh Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237841
- Sponsor's protocol ID
- 50/NDGĐ-HĐĐĐ
- Acronym
- PRECARB-DMP
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18331374
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Carbohydrate Loading in Patients With Well-controlled Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07237841
- Acronym / sponsor ID
- PRECARB-DMP / 50/NDGĐ-HĐĐĐ
- Conditions
- Type2diabetes, Enhanced Recovery After Surgery (ERAS), Fasting, Carbohydrate Loading, Gastric Emptying
- Keywords
- Carbohydrate loading, Preoperative care, Gastric residual, Fasting, ERAS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Gia Dinh People HospitalUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Preoperative carbohydrate loading has been widely recognized as a core component of Enhanced Recovery After Surgery (ERAS) protocols. In non-diabetic patients, drinking a carbohydrate solution two hours before anesthesia improves perioperative metabolic status, reduces insulin resistance, and enhances postoperative recovery without increasing the risk of aspiration or other complications. However, its safety and effectiveness in patients with type 2 diabetes mellitus (T2DM) remain controversial due to concerns about delayed gastric emptying and hyperglycemia.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two groups: interventional group and controlled group.
| Arm | Type | Receives |
|---|---|---|
| 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 | Dietary Supplement: 25% Carbohydrate solution (CHO drinking)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Carbohydrate loading group (25% carbohydrate solution) |
Primary outcome
Capillary blood glucose level (mmol/L) at 4 hours after carbohydrate ingestion
Time frame: 4 hours post-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.
3 secondary outcomes
Capillary blood glucose levels at 1 and 2 hours after ingestion
Time frame: 1 and 2 hours post ingestion
Total intravenous insulin administered for hyperglycemia (>10 mmol/L)
Time frame: Up to 4 hours after ingestion
Proportion of patients with gastric retention (GV/W >1.5 mL/kg)
Time frame: Preoperative (2 hours after ingestion)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 18331374Gustafsson 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huynh Van Binh study director
Nhan dan Gia Dinh Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 25% Carbohydrate solution (CHO drinking) in people with Type2diabetes and Enhanced Recovery After Surgery (ERAS), run by Gia Dinh People Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capillary blood glucose level (mmol/L) at 4 hours after carbohydrate ingestion (time frame: 4 hours post-ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07237841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.