Diabetes MellitusNCT07054476
Intermittent vs Continuous Enteral Nutrition in Glycaemic Control of Diabetic ICU Patients
A study testing Intermittent Enteral Nutrition and Continuous Enteral Nutrition (CE) in people with Diabetes Mellitus and Glycemic Control for Diabetes Mellitus, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Glycemic Control for Diabetes Mellitus, Glycaemia
- What is being tested?
- Intermittent Enteral Nutrition and Continuous Enteral Nutrition (CE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2023to 16 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Diagnosis of diabetes
- Receiving enteral nutrition
- Indication for at least 7 days of ICU admission to perform the study
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altındağ, 06230
About this study
Official title: The Effects of Intermittent and Continuous Enteral Nutrition on Glycaemic Control andSome Metabolic Parameters in Adult Critical Patients With Diabetes Receiving Clinical Nutritional Therapy
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?
Read more
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
Read the 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.
- Being tested
- Intermittent Enteral Nutrition, Continuous Enteral Nutrition (CE)
- Keywords
- Intensive care, continuous enteral nutrition, intermittent enteral nutrition, diabetes, metabolic parameters
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Enteral NutritionOther
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Intermittent Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline (Day 1) and Day 7
Serum Cholesterol Levels (mg/dL)
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.
Measured: Baseline (Day 1) and Day 7
Serum Albumin Levels (g/dL)
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.
Measured: Daily measurements for 7 consecutive days
Serum CRP (C-Reactive Protein) Levels (mg/L)
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.
Measured: Daily measurements for 7 consecutive days
Serum Alanine aminotransferase (ALT) Levels (U/L)
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.
Measured: Daily measurements for 7 consecutive days
Serum Aspartate aminotransferase (AST) Levels (U/L)
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.
Measured: Daily measurements for 7 consecutive days
Serum Gamma glutamyl transferase (GGT) Levels (U/L)
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.
Measured: Daily measurements for 7 consecutive days
Serum Blood Urea Nitrogen (BUN) Levels (mg/dL)
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.
Measured: Daily measurements for 7 consecutive days
Serum Creatinine Levels (mg/dL)
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.
Measured: Daily measurements for 7 consecutive days
Sequential Organ Failure Assessment (SOFA) Score
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.
Measured: First day of admission to the ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start2 Dec 2023
- Primary completion16 Jun 2024
- Study completion16 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Responsible party
- Principal investigator, Irem Nur Aksoylu, Hacettepe University
- Investigators
- Aslı Akyol Mutlu, Prof., Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054476
- Sponsor's protocol ID
- E-93471371-514.99-221892499
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Although ethical approval was obtained for the study, the individual participant data (IPD) were not anonymized during data entry and were recorded in SPSS with identifiable information such as names and surnames. Therefore, due to concerns regarding participant confidentiality and data protection, there is no plan to share the IPD.
Publications
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.
PubMed 34397596
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intermittent and Continuous Enteral Nutrition on Glycaemic Control andSome Metabolic Parameters in Adult Critical Patients With Diabetes Receiving Clinical Nutritional Therapy
- ClinicalTrials.gov ID
- NCT07054476
- Acronym / sponsor ID
- E-93471371-514.99-221892499
- Keywords
- Intensive care, continuous enteral nutrition, intermittent enteral nutrition, diabetes, metabolic parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Ankara Training and Research Hospital
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 16 Jun 2024 (actual)
- Study completion
- 16 Jun 2024 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Continuous Enteral Nutrition Group (CE) | Active comparator | Other: Continuous Enteral Nutrition (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). |
| Intermittent Enteral Nutrition (IE) | Experimental | Other: Intermittent Enteral NutritionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Diagnosis of diabetes
- Receiving enteral nutrition
- Indication for at least 7 days of ICU admission to perform the study
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Enteral NutritionIntermittent 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 | Intermittent Enteral Nutrition (IE) |
| 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). | Other | Continuous Enteral Nutrition Group (CE) |
Primary outcome
Blood Glucose Levels (mg/dL)
Time frame: 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.
10 secondary outcomes
Serum Triglyceride Levels (mg/dL)
Time frame: Baseline (Day 1) and Day 7
Serum Cholesterol Levels (mg/dL)
Time frame: Baseline (Day 1) and Day 7
Serum Albumin Levels (g/dL)
Time frame: Daily measurements for 7 consecutive days
Serum CRP (C-Reactive Protein) Levels (mg/L)
Time frame: Daily measurements for 7 consecutive days
Serum Alanine aminotransferase (ALT) Levels (U/L)
Time frame: Daily measurements for 7 consecutive days
Serum Aspartate aminotransferase (AST) Levels (U/L)
Time frame: Daily measurements for 7 consecutive days
Serum Gamma glutamyl transferase (GGT) Levels (U/L)
Time frame: Daily measurements for 7 consecutive days
Serum Blood Urea Nitrogen (BUN) Levels (mg/dL)
Time frame: Daily measurements for 7 consecutive days
Serum Creatinine Levels (mg/dL)
Time frame: Daily measurements for 7 consecutive days
Sequential Organ Failure Assessment (SOFA) Score
Time frame: First day of admission to the ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Results publication: PubMed 34397596Ren 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.
- Individual participant dataSharing planned: No. Although ethical approval was obtained for the study, the individual participant data (IPD) were not anonymized during data entry and were recorded in SPSS with identifiable information such as names and surnames. Therefore, due to concerns regarding participant confidentiality and data protection, there is no plan to share the IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aslı Akyol Mutlu, Prof. study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Enteral Nutrition and Continuous Enteral Nutrition (CE) in people with Diabetes Mellitus and Glycemic Control for Diabetes Mellitus, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Glucose Levels (mg/dL) (time frame: Five measurements per day at 06:00, 11:00, 16:00, 21:00, and 01:00, for 7 consecutive days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07054476, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.