NCT07054476

Intermittent vs Continuous Enteral Nutrition in Glycaemic Control of Diabetic ICU Patients

The Effects of Intermittent and Continuous Enteral Nutrition on Glycaemic Control andSome Metabolic Parameters in Adult Critical Patients With Diabetes Receiving Clinical Nutritional Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Hacettepe University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus
• Glycemic Control for Diabetes Mellitus
• Glycaemia

Interventions

Type	Name	Description
OTHER	Intermittent Enteral Nutrition	Intermittent Enteral Nutrition (IE): The intervention involves intermittent enteral nutrition using a diabetic-specific enteral formula, administered in 5 separate sessions daily with scheduled breaks between feedings. Each feeding session is followed by a break (1-2 hours). Energy needs are calculated based on the ESPEN guideline (25 kcal/kg/day). This protocol is designed to assess the effects of intermittent feeding in critically ill diabetic patients.
OTHER	Continuous Enteral Nutrition (CE)	Continuous Enteral Nutrition (CE): The intervention involves continuous enteral nutrition provided via a diabetic-specific enteral formula, administered 24 hours a day with 1-hour breaks between feeding sessions. The feeding rate starts at 40cc per hour and is gradually increased based on tolerance. Energy needs are calculated using the ESPEN guideline (25 kcal/kg/day).

Timeline

• Start date: 2023-12-02
• Primary completion: 2024-06-16
• Completion: 2024-06-16
• First posted: 2025-07-08
• Last updated: 2025-07-08

Locations

1 site across 1 country: Turkey (Türkiye)