Impact of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Cardiac Surgery Patients
The Effect of Preoperative Oral Carbohydrate Loading on Insulin Resistance in Pediatric Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Rifdhani Fakhrudin Nur
- 電話番号：+6281390051037
- メール：rifdhani@mail.ugm.ac.id
研究場所
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D.I. Yogyakarta
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Sleman、D.I. Yogyakarta、インドネシア、55281
- RSUP Dr. Sardjito
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コンタクト：
- Instalasi Diklat RSUP Dr. Sardjito
- 電話番号：+628112910226
- メール：diklat@sardjitohospital.co.id
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参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Age 2-16 years.
- ASA physical status 2 or 3
- Good tolerance of enteral feeding
Exclusion Criteria:
- History of type 1 diabetes mellitus.
- History of thyroid insufficiency treated with thyroid medication.
- History of adrenal insufficiency treated with corticosteroids.
- History of gastroesophageal reflux disease.
- Patients receiving preoperative parenteral nutrition.
- Emergency or urgent cardiac surgery.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Carbohydrate Loading (CL)
Participants receive 3 mL/kg body weight of a carbohydrate drink 2 hours before anesthesia induction.
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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.
他の名前：
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プラセボコンパレーター：Placebo Loading (PL)
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
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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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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HOMA-IR (Homeostasis Model Assessment for Insulin Resistance)
時間枠：Baseline, 0 Hour ICU Admission, 24 hours ICU Admission
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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.
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Baseline, 0 Hour ICU Admission, 24 hours ICU Admission
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood Glucose Level
時間枠：Baseline, 0 hour ICU Admission, 24 hours ICU Admission
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Blood glucose measured from central venous samples to assess changes in glucose metabolism during and after cardiac surgery.
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Baseline, 0 hour ICU Admission, 24 hours ICU Admission
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Serum Insulin Concentration
時間枠：Baseline, 0 hour ICU Admission, 24 hours ICU Admission
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Serum insulin level measured from central venous blood samples to characterize perioperative insulin changes.
Higher values indicate higher circulating insulin.
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Baseline, 0 hour ICU Admission, 24 hours ICU Admission
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Exogenous Insulin Dose
時間枠：Baseline, 0 hour ICU Admission, 24 hours ICU Admission
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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.
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Baseline, 0 hour ICU Admission, 24 hours ICU Admission
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Glycemic Variability
時間枠：Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission
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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.
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Baseline, 0 Hour ICU Admission, 24 Hours ICU Admission
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- KE/FK/1142/EC/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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