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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
The tsudy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbohydrate loading | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 just before incision and 24 hour after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Drop out Criteria:
- Intraoperative surgical emergency e.g. massive bleeding
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sardjito General Hospital | Yogyakarta | Special Region of Yogyakarta | 55281 | Indonesia |
The age of participants, glucose level, and insulin level measured will be shared
Data will be available after the completion of the study
Everybody will be able to access the data by personally emailing the study coordinator
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| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000070601 | Diet, Carbohydrate Loading |
| D014867 | Water |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 |
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Only assessor are blinded to the masking. Participants are asked for consent to receive the intervention
| Water (Placebo) | Other | Subjects, at 1 hour prior to surgery, are given just water with the dose of 3 ml/kg body weight |
|
| Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D006878 | Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |