Heart DiseasesNCT06901947
Carbohydrate Loading on Insulin Resistance in Open Heart Surgery
A study testing Glucose drink in people with Heart Diseases, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study is a single-blind randomized clinical trial involving 40 adult patients undergoing elective open-heart surgery. The sample was allocated into two groups: 20 subjects in the oral carbohydrate fluid group and 20 subjects in the water group consumed 2 hours before surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Diseases
- What is being tested?
- Glucose drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2023to 5 Jan 2024
- 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
- Subjects age 18-65 years old undergoing elective open heart surgery
- Subjects giving informed consent
Who cannot join
- Subjects with diabetes mellitus
- Subjects with gastroesophageal reflux
- Subjects with digestive malignancy
- Subjects with dementia
- Subjects with mental health
- Subjects with ASA 4 or more
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Rumah Sakit Cipto Mangunkusumo
Jakarta Pusat, DKI Jakarta, 1043
About this study
Official title: The Effect of Preoperative Oral Carbohydrate Solution Administration of Insulin Resistance in Patients Undergoing Elective Open-Heart Surgery
This study is a single-blind randomized clinical trial involving 40 adult patients undergoing elective open-heart surgery. The sample was allocated into two groups: 20 subjects in the oral carbohydrate fluid group and 20 subjects in the water group consumed 2 hours before surgery. Insulin resistance was measured by blood glucose levels, HOMA-IR index, and insulin tolerance tests. Postoperative outcomes were assessed by ICU stay duration, ventilator use, and hospital stay duration. Patient comfort factors were measured by hunger, thirst, nausea, and comfort levels.
Read the detailed description
In general, preoperative fasting is mandatory for any kind of operations. This is intended to reduce the risk of aspiration during anesthesia procedure. According to recommendation from American Society of Anesthesiologist (ASA), fasting time limit is 8 hours for high calories food, 6 hours for moderate calories food, 4 hours for breastmilk, and 2 hours for clear fluid. Until today, many studies have shown that conventional fasting causes metabolic burden. Lengthy fasting period induces body's stress response, seen in increase in catabolic reaction, elevated contra insulin hormones such as glucocorticoid and catecholamine. In addition to that, surgical stimulus heightens this metabolic reaction which leads to insulin resistance. Insulin resistance causes hyperglycemia, which have a negative impact postoperatively. Several postoperative outcomes have been linked to insulin resistance, such as longer duration of ventilator and hospital stay, as well as the likelihood of postoperative infection. Cardio thorax surgery, as many other major surgeries pose a significant risk of metabolic derangement. Hyperglycemia is known to cause oxidative stress. As the risk of postoperative increases, the mortality and morbidity also increase. In the era of enhanced recovery after surgery, carbohydrate loading is given 2 hours before operation in attempt to improve outcome. Giving 50-250 grams of carbohydrate is expected to suppress catabolic process that usually occurs due to prolonged fasting. This strategy has been implemented in non cardiac surgery, which has shown benefit postoperatively. However, until today there are still limited studies regarding the use of carbohydrate loading on open heart surgeries. The investigators intend to evaluate the benefit of this practice on insulin resistance.
This study was a single-blind randomized clinical trial. The study took place in heart center of Ciptomangunkusumo (RSCM) Hospital and Jakarta Hear Center (JHC) Hospital, for 10 months starting from January 2023 to October 2023. Forty subjects were recruited following the approved ethical clearance by Ethics Committee, Universitas Indonesia. The investigators had a consecutive sampling with inclusion criteria of adult patients aged 18-65 years old who undergo open heart elective surgery and give their consent. The exclusion criteria are those with diabetes mellitus, gastroesophageal reflux, digestive malignancy, dementia, mental disturbances, as well as ASA classification of 4 or more. The drop out criteria applied were those who passed away during operation, experienced hypoglycemia with blood glucose < 70 mg/dl, withdrew from the research, and were not able to finish the data sampling.
- Conditions
- Heart Diseases
- Being tested
- Glucose drink
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose drinkDietary supplement
Intervention group will receive maltodextrin glucose drinks 2 hours prior to the operation
| Study group | Role | What they receive |
|---|---|---|
| Mineral water | No intervention | Patient is given mineral water 2 hours before operation |
| Glucose Drink | Experimental | Patient is given glucose water 2 hours before operation Receives: Dietary Supplement: Glucose drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin resistance difference between two groups
Insulin resistance seen in the level of blood glucose (mg/dL)
Measured: Within 30 minutes before and 30 minutes after operation
Insulin resistance difference between two groups
Insulin resistance seen in the level HOMA-IR (unitless)
Measured: Within 30 minutes before and 30 minutes after operation
Insulin resistance difference between two groups
Insulin resistance seen in the level insulin sensitivity test (%/minute)
Measured: Within 30 minutes before and 30 minutes after operation
Operation outcome difference between two groups
Operation outcome in form of length of stay in the ICU (days)
Measured: From completion of operation to ICU discharge or death, usually under 28 days
Operation outcome difference between two groups
Operation outcome in form of length of stay in the hospital (days)
Measured: From completion of operation to hospital discharge or death, usually under 28 days
Operation outcome difference between two groups
Operation outcome consists of duration of ventilator use (days)
Measured: From completion of operation to cessation of ventilator use or death, usually under 28 days
Subjective well being difference between two groups
Subjective well being in form of hunger (Yes or No)
Measured: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being difference between two groups
Subjective well being in form of thrist (Yes or No)
Measured: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being difference between two groups
Subjective well being in form of nausea (Yes or No)
Measured: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being difference between two groups
Subjective well being in form of comfort (Yes or No)
Measured: Preoperatively in the preparation room, usually around 1 hour before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start1 Jan 2023
- Primary completion10 Oct 2023
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomized controlled trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jefferson K Hidayat, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06901947
- Sponsor's protocol ID
- IndonesiaUAnes060
- Status last verified
- Mar 2025
- First submitted
- 15 Jul 2024
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Oral Carbohydrate Solution Administration of Insulin Resistance in Patients Undergoing Elective Open-Heart Surgery
- ClinicalTrials.gov ID
- NCT06901947
- Acronym / sponsor ID
- IndonesiaUAnes060
- Conditions
- Heart Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 30 Mar 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 study is a single-blind randomized clinical trial involving 40 adult patients undergoing elective open-heart surgery. The sample was allocated into two groups: 20 subjects in the oral carbohydrate fluid group and 20 subjects in the water group consumed 2 hours before surgery. Insulin resistance was measured by blood glucose levels, HOMA-IR index, and insulin tolerance tests. Postoperative outcomes were assessed by ICU stay duration, ventilator use, and hospital stay duration. Patient comfort factors were measured by hunger, thirst, nausea, and comfort levels.
Detailed description
In general, preoperative fasting is mandatory for any kind of operations. This is intended to reduce the risk of aspiration during anesthesia procedure. According to recommendation from American Society of Anesthesiologist (ASA), fasting time limit is 8 hours for high calories food, 6 hours for moderate calories food, 4 hours for breastmilk, and 2 hours for clear fluid. Until today, many studies have shown that conventional fasting causes metabolic burden. Lengthy fasting period induces body's stress response, seen in increase in catabolic reaction, elevated contra insulin hormones such as glucocorticoid and catecholamine. In addition to that, surgical stimulus heightens this metabolic reaction which leads to insulin resistance. Insulin resistance causes hyperglycemia, which have a negative impact postoperatively. Several postoperative outcomes have been linked to insulin resistance, such as longer duration of ventilator and hospital stay, as well as the likelihood of postoperative infection. Cardio thorax surgery, as many other major surgeries pose a significant risk of metabolic derangement. Hyperglycemia is known to cause oxidative stress. As the risk of postoperative increases, the mortality and morbidity also increase. In the era of enhanced recovery after surgery, carbohydrate loading is given 2 hours before operation in attempt to improve outcome. Giving 50-250 grams of carbohydrate is expected to suppress catabolic process that usually occurs due to prolonged fasting. This strategy has been implemented in non cardiac surgery, which has shown benefit postoperatively. However, until today there are still limited studies regarding the use of carbohydrate loading on open heart surgeries. The investigators intend to evaluate the benefit of this practice on insulin resistance.
This study was a single-blind randomized clinical trial. The study took place in heart center of Ciptomangunkusumo (RSCM) Hospital and Jakarta Hear Center (JHC) Hospital, for 10 months starting from January 2023 to October 2023. Forty subjects were recruited following the approved ethical clearance by Ethics Committee, Universitas Indonesia. The investigators had a consecutive sampling with inclusion criteria of adult patients aged 18-65 years old who undergo open heart elective surgery and give their consent. The exclusion criteria are those with diabetes mellitus, gastroesophageal reflux, digestive malignancy, dementia, mental disturbances, as well as ASA classification of 4 or more. The drop out criteria applied were those who passed away during operation, experienced hypoglycemia with blood glucose < 70 mg/dl, withdrew from the research, and were not able to finish the data sampling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Single-blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Mineral water | No intervention | –Patient is given mineral water 2 hours before operation |
| Glucose Drink | Experimental | Dietary Supplement: Glucose drinkPatient is given glucose water 2 hours before operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects age 18-65 years old undergoing elective open heart surgery
- Subjects giving informed consent
Key exclusion criteria (6 listed)
- Subjects with diabetes mellitus
- Subjects with gastroesophageal reflux
- Subjects with digestive malignancy
- Subjects with dementia
- Subjects with mental health
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 |
|---|---|---|
| Glucose drinkIntervention group will receive maltodextrin glucose drinks 2 hours prior to the operation | Dietary supplement | Glucose Drink |
Primary outcome
Insulin resistance difference between two groups
Time frame: Within 30 minutes before and 30 minutes after operation
Insulin resistance seen in the level of blood glucose (mg/dL)
Insulin resistance difference between two groups
Time frame: Within 30 minutes before and 30 minutes after operation
Insulin resistance seen in the level HOMA-IR (unitless)
Insulin resistance difference between two groups
Time frame: Within 30 minutes before and 30 minutes after operation
Insulin resistance seen in the level insulin sensitivity test (%/minute)
Operation outcome difference between two groups
Time frame: From completion of operation to ICU discharge or death, usually under 28 days
Operation outcome in form of length of stay in the ICU (days)
Operation outcome difference between two groups
Time frame: From completion of operation to hospital discharge or death, usually under 28 days
Operation outcome in form of length of stay in the hospital (days)
Operation outcome difference between two groups
Time frame: From completion of operation to cessation of ventilator use or death, usually under 28 days
Operation outcome consists of duration of ventilator use (days)
Subjective well being difference between two groups
Time frame: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being in form of hunger (Yes or No)
Subjective well being difference between two groups
Time frame: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being in form of thrist (Yes or No)
Subjective well being difference between two groups
Time frame: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being in form of nausea (Yes or No)
Subjective well being difference between two groups
Time frame: Preoperatively in the preparation room, usually around 1 hour before operation
Subjective well being in form of comfort (Yes or No)
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 2 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose drink in people with Heart Diseases, run by Universitas Indonesia at 1 site in Indonesia.
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 2 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 2 Apr 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 Indonesia. 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?
Insulin resistance difference between two groups (time frame: Within 30 minutes before and 30 minutes after operation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2025.