Insulin ResistanceNCT07545538
Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Surgery
A study testing Carbohydrate loading in people with Insulin Resistance, run by Gadjah Mada University at 1 site in Indonesia.
Trial summary
It is a double blinded randomized controlled trial interventional study, examining the effect of carb loading given prior to surgery on preventing post operative insulin resistance in pediatric patients undergoing elective surgery Read more about this study
- Who is it for?
- Ages 2 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Carbohydrate loading
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA Physical Status I and II
- Able to tolerate enteral feeding
- Subjects are undergoing surgery with general anesthesia
Who cannot join
- Subjects consume corticosteroids and insulin
- Subjects have endocrine disorder, gastroesophageal reflux disease and psychiatric disorder
- Subjects are treated with preoperative parenteral nutrition
- The surgical procedure is longer than 4 hours
- Drop out Criteria:
- Intraoperative surgical emergency e.g. massive bleeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Sardjito General Hospital
Yogyakarta, Special Region of Yogyakarta, 55281
About this study
Official title: The Effectiveness of Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Patients Undergoing Elective Surgery
It is a double blinded randomized controlled trial interventional study, examining the effect of carb loading given prior to surgery on preventing post operative insulin resistance in pediatric patients undergoing elective surgery
Read the detailed description
The tsudy
- Conditions
- Insulin Resistance
- Being tested
- Carbohydrate loading, Water (Placebo)
- Keywords
- insulin resistance, HOMA-IR, pediatric surgery
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate loadingOther
Subjects, at 1 hour prior to surgery, are given liquid containing Dextrose10% with osmolality of 191,92mOsm/L and energy of 34 kcal/100 cc. The dose is 3 ml/kg body weight
Water (Placebo)Other
Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate loading | Experimental | Subjects, at 1 hour prior to surgery, are given liquid containing Dextrose10% with osmolality of 191,92mOsm/L and energy of 34 kcal/100 cc. The dose is 3 ml/kg body weight Receives: Other: Carbohydrate loading |
| Placebo | Placebo comparator | Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight Receives: Other: Water (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance
Insulin resistance is measured using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), with the formula of (Insulin concentration x Glucose concentration)/22.5
Measured: measured just before incision and 24 hour after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jan 2024
- Primary completion30 Apr 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunita Widyastuti, Gadjah Mada University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545538
- Sponsor's protocol ID
- KE/FK/0951/EC/2024
- Status last verified
- Apr 2026
- First submitted
- 16 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The age of participants, glucose level, and insulin level measured will be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Carbohydrate Loading in Lowering Perioperative Insulin Resistance in Pediatric Patients Undergoing Elective Surgery
- ClinicalTrials.gov ID
- NCT07545538
- Acronym / sponsor ID
- KE/FK/0951/EC/2024
- Conditions
- Insulin Resistance
- Keywords
- insulin resistance, HOMA-IR, pediatric surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 22 Apr 2026 (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.
It is a double blinded randomized controlled trial interventional study, examining the effect of carb loading given prior to surgery on preventing post operative insulin resistance in pediatric patients undergoing elective surgery
Detailed description
The tsudy
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate loading | Experimental | Other: Carbohydrate loadingSubjects, at 1 hour prior to surgery, are given liquid containing Dextrose10% with osmolality of 191,92mOsm/L and energy of 34 kcal/100 cc. The dose is 3 ml/kg body weight |
| Placebo | Placebo comparator | Other: Water (Placebo)Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight |
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA Physical Status I and II
- Able to tolerate enteral feeding
- Subjects are undergoing surgery with general anesthesia
Key exclusion criteria (6 listed)
- Subjects consume corticosteroids and insulin
- Subjects have endocrine disorder, gastroesophageal reflux disease and psychiatric disorder
- Subjects are treated with preoperative parenteral nutrition
- The surgical procedure is longer than 4 hours
- Intraoperative surgical emergency e.g. massive bleeding
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 |
|---|---|---|
| Carbohydrate loadingSubjects, at 1 hour prior to surgery, are given liquid containing Dextrose10% with osmolality of 191,92mOsm/L and energy of 34 kcal/100 cc. The dose is 3 ml/kg body weight | Other | Carbohydrate loading |
| Water (Placebo)Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight | Other | Placebo |
Primary outcome
Insulin Resistance
Time frame: measured just before incision and 24 hour after surgery
Insulin resistance is measured using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), with the formula of (Insulin concentration x Glucose concentration)/22.5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. The age of participants, glucose level, and insulin level measured will be shared
Related trials for Insulin Resistance
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingPhase 2
Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity
Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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.
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 Carbohydrate loading in people with Insulin Resistance, run by Gadjah Mada University 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 3 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: enrolling by invitation, as of the sponsor's last update on 1 May 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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 (time frame: measured just before incision and 24 hour after surgery). 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 1 May 2026.