An interventional study of Oral Carbohydrate Drink (Maltodextrin) and Placebo (Water) in Cardiac Surgery and Insulin Resistance, sponsored by Rifdhani Fakhrudin Nur. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-08.
Sponsored by Rifdhani Fakhrudin Nur · Not applicable, Interventional, and Supportive care
Among 20 studies in Insulin Resistance with a site in Indonesia — 4 open to participants now, 4 under way, none of them phase 3. Insulin Resistance · Indonesia.
Among the 20 studies in Insulin Resistance with a site in Indonesia, this one is the 9th largest by enrollment of the 18 interventional ones that give a count, is one of 4 that started in 2024, is one of 13 with no phase, and was the 15th registered.
2,969 studies on the registry are indexed under Insulin Resistance; 338 are open to participants now.
Browse Insulin Resistance studies →4 of the 20 studies in Insulin Resistance with a site in Indonesia are open now. Recruiting first, the newest first:
Gadjah Mada University · Sites in Indonesia
Rifdhani Fakhrudin Nur · Sites in Indonesia
Andalas University · Sites in Indonesia
Andina Setyawati · Sites in Indonesia
A study can be open while its sites in Indonesia have not opened yet or have stopped. Only those recruiting at a site in Indonesia →
Of the 244 Insulin Resistance studies recruiting now, 54 (22%) set no upper age limit and 158 (65%) stop at 75 or younger; 30 take children under 18; 113 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
20 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 2009; this study’s year is marked. 4 started in 2024.
This study's enrollment of 50 is above the median of 40 across 2,369 interventional studies indexed under Insulin Resistance.
Median enrollment 50 across the 18 interventional studies, 339 across the 2 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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2 of 20 have an industry lead sponsor. The 10 most frequent:
Rifdhani Fakhrudin Nur is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Rifdhani Fakhrudin Nur has 2 studies filed under Insulin Resistance — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 20 studies in Insulin Resistance with a site in Indonesia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to investigate the effect of preoperative oral carbohydrate on insulin resistance in adult cardiac surgery patients with a cardiopulmonary bypass machine. Insulin resistance is when the body does not respond well to insulin, which can raise blood sugar and slow recovery.
The main question this study aims to answer is:
Does drinking a carbohydrate drink 2 hours before surgery lower insulin resistance compared to drinking only water after on pump cardiac surgery?
Researchers will compare two groups:
One group will drink 400 milliliters of a maltodextrin (carbohydrate) drink (CL group). The other group will drink 400 milliliters of water (PL group).
Participants will:
This prospective, randomized controlled trial is designed to evaluate whether preoperative oral carbohydrate loading reduces perioperative insulin resistance in adults undergoing elective cardiac surgery at Dr. Sardjito Hospital, Yogyakarta, Indonesia. Fifty participants aged 20-60 years with American Society of Anesthesiologists (ASA) physical status II-III will be randomly assigned to one of two groups:
All participants will follow standard preoperative fasting guidelines. Blood samples for glucose and insulin will be taken immediately after induction of anesthesia, upon ICU admission (hour 0), and at hour 24 in the ICU. The main outcome is the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include perioperative glucose levels and postoperative insulin requirements.
Randomization is computer-generated, with allocation concealed until assignment. Surgeons, anesthesiologists, ICU staff, outcome assessors, and data analysts will be blinded to group allocation. The sample size of 50 participants (25 per group) was calculated based on prior effect sizes, with 80% power and a two-sided alpha of 0.05.
Data will be analyzed using descriptive statistics and appropriate tests for continuous and categorical variables. Between-group comparisons will use Student's t-test or Mann-Whitney U test as appropriate. Normality will be assessed by Shapiro-Wilk test. Repeated measures will be analyzed with paired tests or ANCOVA models. A p-value \<0.05 will be considered statistically significant.
This study is expected to provide new evidence on whether preoperative carbohydrate loading can reduce insulin resistance in the specific context of cardiac surgery, and potentially improve perioperative management and patient recovery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Dropout criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 400 mL of a maltodextrin-based carbohydrate drink 2 hours before surgery. The drink contains 50 g of carbohydrate (maltodextrin).
Dietary Supplement: Oral Carbohydrate Drink (Maltodextrin)
Participants receive 400 mL of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group.
Other: Placebo (Water)
Participants receive 400 mL of a clear beverage containing 50 g of maltodextrin (carbohydrate) 2 hours before anesthesia induction. The drink is used to lower insulin resistance and improve perioperative recovery.
Also known as: Preoperative carbohydrate loading drink
Participants receive 400 mL of plain water 2 hours before anesthesia induction, following the same protocol and timing as the carbohydrate drink group.
Also known as: Clear water placebo
HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is calculated as fasting insulin (µU/mL) × fasting glucose (mmol/L) / 22.5. Higher values indicate greater insulin resistance.
Time frame: baseline, 0 hour ICU admission, and 24 hours ICU admission
Perioperative Blood Glucose Levels
Blood glucose measured from central venous samples to assess changes in glucose metabolism during and after cardiac surgery.
Time frame: baseline, 0 hour ICU admission, and 24 hours ICU admission
Perioperative Serum Insulin Concentration
Serum insulin level measured from central venous blood samples to characterize perioperative insulin changes. Higher values indicate higher circulating insulin.
Time frame: baseline, 0 hour ICU admission, and 24 hours ICU admission
Plan to share: Yes — De-identified individual participant data (IPD) will be made available upon reasonable request to the corresponding investigator after publication of study results.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Ran from Jan 2024 to primary completion in May 2024, 4 months.
Of 714 non-industry interventional studies with no phase under Insulin Resistance, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 4 months is below that.
Counting every sponsor, half of 754 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Carbohydrate Supplement Drink
Rifdhani Fakhrudin Nur