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

NCT07054476 | Completed

• 1 other identifier: E-93471371-514.99-221892499
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus; Glycemic Control for Diabetes Mellitus; Glycaemia

Keywords

Intensive care; continuous enteral nutrition; intermittent enteral nutrition; diabetes; metabolic parameters

Outcome Measures

Primary Outcomes (1)

• Blood Glucose Levels (mg/dL)

  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.

  Five measurements per day at 06:00, 11:00, 16:00, 21:00, and 01:00, for 7 consecutive days

Secondary Outcomes (10)

• Serum Triglyceride Levels (mg/dL)

  Baseline (Day 1) and Day 7

• Serum Cholesterol Levels (mg/dL)

  Baseline (Day 1) and Day 7

• Serum Albumin Levels (g/dL)

  Daily measurements for 7 consecutive days

• Serum CRP (C-Reactive Protein) Levels (mg/L)

  Daily measurements for 7 consecutive days

• Serum Alanine aminotransferase (ALT) Levels (U/L)

  Daily measurements for 7 consecutive days

Study Arms (2)

Continuous Enteral Nutrition Group (CE)

ACTIVE COMPARATOR

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).

Other: Continuous Enteral Nutrition (CE)

Intermittent Enteral Nutrition (IE)

EXPERIMENTAL

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.

Other: Intermittent Enteral Nutrition

Interventions

Intermittent Enteral Nutrition 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.

Intermittent Enteral Nutrition (IE)

Continuous Enteral Nutrition (CE) 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).

Continuous Enteral Nutrition Group (CE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Diagnosis of diabetes
• Receiving enteral nutrition
• Indication for at least 7 days of ICU admission to perform the study

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hacettepe University: lead
• Ankara Training and Research Hospital: collaborator

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altındağ, 06230, Turkey (Türkiye)

Location

Related Publications (1)

• Ren CJ, Yao B, Tuo M, Lin H, Wan XY, Pang XF. Comparison of sequential feeding and continuous feeding on the blood glucose of critically ill patients: a non-inferiority randomized controlled trial. Chin Med J (Engl). 2021 Jul 20;134(14):1695-1700. doi: 10.1097/CM9.0000000000001684.

  PMID: 34397596 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Aslı Akyol Mutlu, Prof.

  Hacettepe University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dietitian

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: July 8, 2025
• Study Start: December 2, 2023
• Primary Completion: June 16, 2024
• Study Completion: June 16, 2024
• Last Updated: July 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)