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

Hacettepe University

Status: Completed

Conditions: Glycemic Control for Diabetes Mellitus; Glycaemia; Diabetes Mellitus

Treatments: Other: Intermittent Enteral Nutrition; Other: Continuous Enteral Nutrition (CE)

Study type: Interventional

Funder types: Other

Identifiers

NCT07054476

E-93471371-514.99-221892499

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older

Diagnosis of diabetes

Receiving enteral nutrition

Indication for at least 7 days of ICU admission to perform the study

Exclusion criteria

• 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Continuous Enteral Nutrition Group (CE)

Active Comparator group

Description:

Participants in this arm received continuous enteral nutrition based on the existing hospital protocol. After reaching 80% of the target energy requirements without signs of feeding intolerance, patients were provided with diabetic-specific enteral formula administered continuously. Energy needs were calculated using the ESPEN guideline (25 kcal/kg/day).

Treatment:

Other: Continuous Enteral Nutrition (CE)

Intermittent Enteral Nutrition (IE)

Experimental group

Description:

Participants in this arm received intermittent enteral nutrition as part of the study protocol. After reaching 80% of the target energy requirements without signs of feeding intolerance, patients were provided with diabetic-specific enteral formula administered in 5 discrete sessions across the 24-hour period, with scheduled breaks between feeding sessions. Energy needs were calculated using the ESPEN guideline (25 kcal/kg/day). This intervention was designed to compare the effects of intermittent feeding schedules against continuous feeding in critically ill diabetic patients.

Treatment:

Other: Intermittent Enteral Nutrition