The Effects of Preoperative Carbohydrate Loading on Perioperative Blood Glucose Levels and Insulin Resistance in Type 2 Diabetes Mellitus Patients Undergoing Elective Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Perioperative Blood Glucose Level
研究概览
简要总结
The goal of this clinical trial is to learn the effects of preoperative carbohydrate loading on perioperative blood glucose levels and insulin resistance in type 2 diabetes mellitus undergo elective surgery. The main questions it aims to answer are:
- Does carbohydrate loading affects perioperative blood glucose and insulin resistance in type 2 diabetes mellitus patients undergo surgery?
- How are the incident of perioperative hyperglycemia and hypoglycemia between subjects who receive placebo compared with subjects who receive carbohydrate loading
- How are the hyperglycemia-related complications comparison between two groups?
Researchers will compare the carbohydrate loading intervention to placebo (regular drinking water with zero-calorie sweetener) to see the effects of carbohydrate loading to blood glucose levels and insulin resistance (by HOMA-IR value)
Participants will:
- randomized to carbohydrate loading (CHO) group or placebo
- checked for preoperative, intraoperative, postoperative blood glucose, and preoperative and postoperative insulin level
- evaluated for any hyperglycaemia-related complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Controlled type 2 diabetes mellitus with any treatment
- •BMI <30 kg/m2
- •Non-major elective surgery
排除标准
- •Subject refusal
- •Geriatric patients with frailty score >4
- •Subjects with critical illness
- •Subjects received steroid treatment
- •Subjects received total parenteral nutrition
- •Subjects with intestinal obstruction
- •Subjects with impaired liver function
研究组 & 干预措施
Carbohydrate loading (CHO) group
Patient received preoperative carbohydrate loading of 200 ml Maltodextrin 12.5%, given 2 hours before the operation
干预措施: preoperative carbohydrate loading (Other)
Control
Patient received preoperative regular drinking water of 200 ml with zero-calorie sweetener, given 2 hours before the operation
干预措施: Placebo (Other)
结局指标
主要结局
Perioperative Blood Glucose Level
时间窗: Preoperative (before intervention), 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative
Blood glucose sampled from vein and capillary, measured in mg/dL
Insulin Resistance
时间窗: preoperative and 30 minutes postoperative
Calculated using Homeostasis Model Assessment Insulin Resistance (HOMA-IR), obtained from measured fasting insulin (μU/ml) × fasting glucose (mmol/l) / 22.5
次要结局
- Abnormal blood glucose incidence(Preoperative, 1 hour intraoperative, 30 minutes postoperative, 1 day postoperative)
- Complications(Up to 1 week postoperative or discharged from hospital stay)
研究者
Aries Perdana
Staff of Departement of Anesthesiology and Intensive Care, Division of Cardiac Anesthesia
Indonesia University