Intermittent vs Continuous Enteral Nutrition in Glycaemic Control of Diabetic ICU Patients
- Conditions
- Diabetes MellitusGlycemic Control for Diabetes MellitusGlycaemia
- Registration Number
- NCT07054476
- Lead Sponsor
- Hacettepe University
- Brief Summary
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
- Detailed Description
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.
Energy needs were estimated using the ESPEN guideline formula (25 kcal/kg/day), and a diabetic-specific enteral formula was administered accordingly.
Blood glucose levels were measured five times per day (06:00, 11:00, 16:00, 21:00, and 01:00) using a bedside glucometer. In addition, all participants had the following data collected:
Clinical scores: SOFA, mNUTRIC, and APACHE II
Baseline and Day 7 measurements of serum total cholesterol and triglycerides
Daily laboratory parameters: serum glucose, ALT, AST, GGT, albumin, CRP, BUN, creatinine, sodium, and potassium
The intervention lasted for 7 days and aimed to evaluate whether the method of enteral nutrition delivery (CE vs. IE) affects metabolic responses and glycemic outcomes in diabetic ICU patients. Findings from this study may help inform nutritional strategies in critical care for individuals with diabetes.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Age 18 or older
Diagnosis of diabetes
Receiving enteral nutrition
Indication for at least 7 days of ICU admission to perform the study
- Under 18 years old
Having specific needs that would require a completely different type of treatment, such as cancer or cystic fibrosis
Pregnancy
Expected to stay in the ICU for less than 7 days
Receiving oral feeding or TPN (Total Parenteral Nutrition)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Blood Glucose Levels (mg/dL) 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.
- Secondary Outcome Measures
Name Time Method Serum Triglyceride Levels (mg/dL) Baseline (Day 1) and Day 7 Serum triglyceride levels will be measured to assess the impact of enteral nutrition on lipid metabolism. Blood samples will be collected at baseline (Day 1) and on Day 7 of intervention.
Serum CRP (C-Reactive Protein) Levels (mg/L) Daily measurements for 7 consecutive days Serum CRP levels will be monitored to evaluate the inflammatory response in critically ill patients receiving enteral nutrition. Blood samples will be drawn daily for 7 days.
Serum Aspartate aminotransferase (AST) Levels (U/L) Daily measurements for 7 consecutive days Serum levels of AST will be monitored to assess liver function and potential liver injury in response to enteral nutrition protocols. Blood samples will be drawn daily for 7 days.
Serum Cholesterol Levels (mg/dL) Baseline (Day 1) and Day 7 Serum cholesterol levels will be measured to assess the impact of enteral nutrition on lipid metabolism. Blood samples will be collected at baseline (Day 1) and on Day 7 of intervention.
Sequential Organ Failure Assessment (SOFA) Score First day of admission to the ICU The SOFA score evaluates the function of six organ systems-respiratory, cardiovascular, hepatic, coagulation, renal, and neurological-in critically ill patients. It is used to monitor the extent of organ dysfunction and predict clinical outcomes in the intensive care unit (ICU). Unit of Measure: Score (0-24 scale) Interpretation: Higher scores indicate greater organ dysfunction and worse prognosis.
Serum Albumin Levels (g/dL) Daily measurements for 7 consecutive days Serum albumin levels will be assessed as an indicator of nutritional status and response to enteral feeding protocols. Blood samples will be drawn daily for 7 days.
Serum Alanine aminotransferase (ALT) Levels (U/L) Daily measurements for 7 consecutive days Serum levels of ALT will be monitored to assess liver function and potential liver injury in response to enteral nutrition protocols. Blood samples will be drawn daily for 7 days.
Serum Gamma glutamyl transferase (GGT) Levels (U/L) Daily measurements for 7 consecutive days Serum levels of GGT will be monitored to assess liver function and potential liver injury in response to enteral nutrition protocols. Blood samples will be drawn daily for 7 days.
Serum Blood Urea Nitrogen (BUN) Levels (mg/dL) Daily measurements for 7 consecutive days Serum levels of BUN will be assessed to evaluate kidney function in critically ill patients receiving enteral nutrition. Blood samples will be drawn daily for 7 days.
Serum Creatinine Levels (mg/dL) Daily measurements for 7 consecutive days Serum levels of creatinine will be assessed to evaluate kidney function in critically ill patients receiving enteral nutrition. Blood samples will be drawn daily for 7 days.
Trial Locations
- Locations (1)
Ankara Training and Research Hospital
🇹🇷Ankara, Altındağ, Turkey
Ankara Training and Research Hospital🇹🇷Ankara, Altındağ, Turkey