The Effects of Intermittent and Continuous Enteral Nutrition on Glycaemic Control andSome Metabolic Parameters in Adult Critical Patients With Diabetes Receiving Clinical Nutritional Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Blood Glucose Levels (mg/dL)
研究概览
简要总结
The goal of this clinical trial is to learn if intermittent or continuous enteral nutrition applications can improve glycemic control and affect certain metabolic parameters in adult critically ill patients with diabetes receiving clinical nutrition therapy. The main questions it aims to answer are:
Does intermittent enteral nutrition lead to better glycemic control compared to continuous enteral nutrition?
How do intermittent and continuous enteral nutrition applications affect metabolic parameters such as serum insulin levels, lipid profile, and inflammatory markers?
Researchers will compare intermittent and continuous enteral nutrition groups to see if one method is more effective in improving glycemic control and metabolic outcomes.
Participants will:
Receive either intermittent or continuous enteral nutrition as part of their clinical nutrition therapy
Have regular blood tests to monitor blood glucose, insulin, lipid profile, and inflammatory markers
Be monitored for glycemic variability and metabolic changes during their ICU stay
详细描述
This randomized controlled clinical trial was conducted in the 25-bed tertiary intensive care unit of the Anesthesiology and Reanimation Department at Ankara Training and Research Hospital. Ethical approval was obtained from the institutional review board, and written informed consent was provided by the legal representatives of all participants. The study was carried out between December 2023 and June 2024, including 25 adult diabetic patients (14 males, 11 females; mean age: 73.44 ± 8.97 years) who were receiving clinical nutrition therapy in the ICU.
The purpose of this study was to compare the effects of continuous enteral nutrition (CE) and intermittent enteral nutrition (IE) on glycemic control and selected metabolic parameters. Sample size was calculated using G*Power software, indicating that a minimum of 24 participants (12 per group) would be needed to detect a large effect size (1.39) with 80% power and a 5% type I error rate.
All patients initially began enteral feeding at 40 mL/hour according to standard ICU protocol, with gradual increases based on individual tolerance. Once patients reached 80% of their estimated energy requirement without feeding intolerance, they were randomized into one of two groups:
CE group (Control, n=12): Received enteral nutrition in a near-continuous fashion with scheduled breaks.
IE group (n=13): Received nutrition in defined intermittent periods, alternating with fasting intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants were blinded to group assignment. Neither the continuous (CE) nor intermittent (IE) feeding method was disclosed to the patients due to their critical illness status. However, care providers, investigators, and outcome assessors were aware of the group assignments.
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
- •Age 18 or older
- •Diagnosis of diabetes
- •Receiving enteral nutrition
- •Indication for at least 7 days of ICU admission to perform the study
排除标准
- •Under 18 years old
- •Having specific needs that would require a completely different type of treatment, such as cancer or cystic fibrosis
- •Expected to stay in the ICU for less than 7 days
- •Receiving oral feeding or TPN (Total Parenteral Nutrition)
结局指标
主要结局
Blood Glucose Levels (mg/dL)
时间窗: Five measurements per day at 06:00, 11:00, 16:00, 21:00, and 01:00, for 7 consecutive days
The primary outcome measure will be the effect of continuous versus intermittent enteral nutrition on glycemic control in critically ill diabetic patients. Blood glucose levels will be monitored 5 times per day using a glucose meter (GlucoNavii, Korea). Measurements will be taken at the following times: 06:00, 11:00, 16:00, 21:00, and 01:00.
次要结局
- Serum Triglyceride Levels (mg/dL)(Baseline (Day 1) and Day 7)
- Serum CRP (C-Reactive Protein) Levels (mg/L)(Daily measurements for 7 consecutive days)
- Serum Aspartate aminotransferase (AST) Levels (U/L)(Daily measurements for 7 consecutive days)
- Serum Cholesterol Levels (mg/dL)(Baseline (Day 1) and Day 7)
- Sequential Organ Failure Assessment (SOFA) Score(First day of admission to the ICU)
- Serum Albumin Levels (g/dL)(Daily measurements for 7 consecutive days)
- Serum Alanine aminotransferase (ALT) Levels (U/L)(Daily measurements for 7 consecutive days)
- Serum Gamma glutamyl transferase (GGT) Levels (U/L)(Daily measurements for 7 consecutive days)
- Serum Blood Urea Nitrogen (BUN) Levels (mg/dL)(Daily measurements for 7 consecutive days)
- Serum Creatinine Levels (mg/dL)(Daily measurements for 7 consecutive days)
研究者
Irem Nur Aksoylu
Dietitian
Hacettepe University