An interventional study of Carbohydrate and placebo solution in Cardiac Surgery, Insulin Resistance and Pediatric Cardiac Surgery, sponsored by Rifdhani Fakhrudin Nur. Not yet recruiting at 1 site in Indonesia. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-07-27.
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 12th largest by planned enrollment of the 18 interventional ones that give a count, is one of 2 that started in 2026, is one of 13 with no phase, and was the 19th 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
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: 2 Years to 16 Years · 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. 2 started in 2026.
This study's planned enrollment of 44 is close to 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.
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Surgical stress and preoperative fasting can induce insulin resistance, characterized by impaired cellular response to insulin and resulting hyperglycemia. In pediatric patients undergoing cardiac surgery, this metabolic stress response may negatively affect postoperative recovery. Although preoperative oral carbohydrate loading, defined as administering a carbohydrate-rich beverage before surgery rather than prolonged fasting, has demonstrated efficacy in reducing postoperative insulin resistance in adults, evidence supporting its use in pediatric cardiac surgery remains limited.
This randomized controlled trial aims to determine whether preoperative oral carbohydrate loading reduces perioperative insulin resistance, as measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), in pediatric patients undergoing cardiac surgery. The study will compare outcomes between children who receive an oral carbohydrate beverage prior to surgery and those who follow standard preoperative fasting protocols.
This study is a prospective, single-blind, randomized controlled trial of pediatric patients who underwent elective cardiac surgery at Dr. Sardjito General Hospital, Yogyakarta, Indonesia, from April to August 2026. The study sample consisted of pediatric patients aged 2-16 years with an ASA physical status of 2 or 3 who had good tolerance for enteral fluid administration. Patients will be randomly assigned to one of two groups: 1. Intervention Group (Carbohydrate Loading): 3 mL/kg body weight of a maltodextrin-based carbohydrate drink 2 hours before anesthesia; 2. Control Group (Placebo Loading): 3 mL/kg body weight of plain water 2 hours before anesthesia. All patients will follow standard preoperative fasting guidelines. Blood samples for glucose and insulin testing will be collected immediately after induction (baseline), at 0 hours of Intensive Care Unit (ICU) admission, and at 24 hours of ICU admission. The primary outcome is the Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Secondary outcomes include blood glucose levels, serum insulin concentration, exogenous insulin dose, and glycemic variability.
All study participants will undergo preoperative assessment, followed by a carbohydrate-loading protocol, and assessment of blood glucose levels, insulin resistance, exogenous insulin administration, and intraoperative and postoperative glycemic variability. Numerical data will be presented as means and standard deviations. Categorical data will be presented as counts and percentages. The Shapiro-Wilk normality test will be applied to all numerical data. Subject characteristics between the two groups will be compared using the Chi-square test for categorical data and the t-test (for normally distributed data) or the Mann-Whitney test (for non-normally distributed data) for numerical data. Pre- and postoperative HOMA-IR values will be compared using a paired t-test if the data are normally distributed, or a two-way ANCOVA (univariate GLM) if they are not. A p-value \< 0.05 will be considered statistically significant.
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:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction.
Dietary Supplement: Carbohydrate
Participants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group
Other: placebo solution
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction. The drink is used to lower insulin resistance and improve perioperative recovery.
Also known as: preoperative carbohydrate loading drink, Oral carbohydrate drink
Participants receive 3 mL/kg body weight of plain water 2 hours before surgery, following the same timing and fasting protocol as the experimental group.
Also known as: Clear water placebo, Plain water
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, 24 hours ICU Admission
Blood Glucose Level
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, 24 hours ICU Admission
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, 24 hours ICU Admission
Exogenous Insulin Dose
Total daily dose of exogenous insulin (basal and/or bolus) required to achieve glycemic control will be recorded, expressed in units per day (U/day) or units per kilogram body weight per day (U/kg/day). Change in insulin dose from baseline will be used to reflect changes in insulin requirement/sensitivity.
Time frame: Baseline, 0 hour ICU Admission, 24 hours ICU Admission
Glycemic Variability
Glycemic variability is defined as the fluctuation of blood glucose levels during the perioperative period, calculated from serial blood glucose measurements. Variability will be expressed as the standard deviation (SD) and/or coefficient of variation (%CV) of serial glucose values (numeric/continuous scale). Higher SD/CV values indicate greater glycemic fluctuation during the perioperative period.
Time frame: Baseline, 0 Hour ICU Admission, 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
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Oct 2026, 2 months later.
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 planned 2 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 not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Carbohydrates
Rifdhani Fakhrudin Nur