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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-02

Study Completion Date

2024-06-16

Brief Summary

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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

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Detailed Description

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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

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Diabetes Mellitus Glycemic Control for Diabetes Mellitus Glycaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study used a parallel assignment model in which participants were randomized into two separate intervention groups: Continuous Enteral Nutrition (CE) and Intermittent Enteral Nutrition (IE). Each participant remained in their assigned group for the entire 7-day intervention period without crossover between groups.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

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.

Study Groups

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Continuous Enteral Nutrition Group (CE)

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).

Group Type ACTIVE_COMPARATOR

Continuous Enteral Nutrition (CE)

Intervention Type OTHER

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).

Intermittent Enteral Nutrition (IE)

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.

Group Type EXPERIMENTAL

Intermittent Enteral Nutrition

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No