NutritionNCT06564168
Nutritional Status of Critically Ill Diabetic Patients
An observational study of Nutrition and Critical Illness, run by Assiut University.
Trial summary
1. To investigate the nutritional status of patients with type 2 diabetes mellitus in the intensive care unit. 2. To detect the impact of nutritional status on outcome (mortality, length of hospital stay,duration of mechanical ventilation, and need for renal replacement therapy) Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Nutrition, Critical Illness, Diabetes Mellitus, Type 2
- How many people
- 430 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Mar 2026
- Phase
- Observational
- 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 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients who are admitted to the intensive care unit will be enrolled and divided into two groups. Group 1: includes all candidates with type 2 diabetes and meet the inclusion criteria and group 2: the control group includes patients without diabetes. All patients after informed consent will be subjected to: A: History. B: Examination. C: laboratory data: urea and creatinine, liver function test, and complete blood count. D: Nutritional status assessment scores: 1. Nutritional risk score (NRS)-2002. 2. Nutrition Risk in Critically ill (NUTRIC) score.
Who may be able to join
- Age above 18 years. Diabetic type ll. Admitted for more than 48 hours.
Who cannot join
- Type 1 Diabetes Mellitus. Age under 18 years Readmission in intensive care unit. Adimssion for less than 48 hours
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Nutritional Status of Critically Ill Diabetic Patients With Type 2 Diabetes Mellitus.
- To investigate the nutritional status of patients with type 2 diabetes mellitus in the intensive care unit.
- To detect the impact of nutritional status on outcome (mortality, length of hospital stay,duration of mechanical ventilation, and need for renal replacement therapy)
Read the detailed description
Nutrition support in the Intensive Care Unit is very important since it has a significant impact on recovery from illness and overall outcome. Patients in the intensive care unit have a higher risk of malnutrition than patients undergoing general admission to hospitals . In critically ill patients, malnutrition may result in impaired immunological function, impaired ventilatory drive, and weakened respiratory muscles, leading to prolonged ventilatory dependence and increased infectious morbidity and mortality.
An appropriate nutritional support is indispensable to critically ill patients, who are almost at the hyper-metabolic state of their clinical condition such as trauma, sepsis, and major surgery. These critical conditions result in a disproportional release of cytokine and stress hormones that alter energy and protein metabolism and eventually lead to malnourishment.
A recent systematic review revealed the strikingly high prevalence of malnutrition in intensive care unit patients (ranged from 38% to 78%), which is associated with the patients' increased morbidity, mortality, and hospital-related cost.The increased dependency on mechanical ventilation, length of hospital stay, intensive care unit readmission, persistence of infection, and risk of hospital mortality associated with undernutrition, make it an important dilemma in the care of Intensive Care unit patients.
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood glucose.( and associated with serious complications, demand for multimodal treatment, and significant economic burden With the development of complications and hospital lengths of stay, life expectancy is worsened with diabetes, and nutritional status is generally correlated with these total outcomes.
In this research,investigators will evaluate the nutritional state in critically ill diabetic patients with type 2 diabetes mellitus, and detect the impact of poor nutritional status on out comes regarding mortality, length of hospital stay , length of mechanical ventilation, and need for renal replacement therapy.
- Conditions
- Nutrition, Critical Illness, Diabetes Mellitus, Type 2
- Medical subject headings
- Critical Illness, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Crtitically ill Patients with diabetes mellitus type 2. | |
| Controls | All critically ill patients not Diabetes mellitus type 2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Diabetes Mellitus and malnutrition in critically ill patients
By using non invasive methods to find a correlation between Diabetes mellitus and malnutrition in critically ill patients by history and examination and scores of nutrition
Measured: through study completion, an average of 1 year]
Outcome of patients with Diabetes Mellitus admitted in intensive care unit
As Diabetic patiants are more suspectible to face malnutrition in intensive care unit so non invasive methods as history, examination, score to improve outcome and decrease morbidity and mortality.
Measured: through study completion, an average of 1 year]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study startOct 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salwa Ahmed Mohammed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564168
- Sponsor's protocol ID
- Nutrition in Diabetes Mellitus
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sioson MS, Martindale R, Abayadeera A, Abouchaleh N, Aditianingsih D, Bhurayanontachai R, Chiou WC, Higashibeppu N, Mat Nor MB, Osland E, Palo JE, Ramakrishnan N, Shalabi M, Tam LN, Ern Tan JJ. Nutrition therapy for critically ill patients across the Asia-Pacific and Middle East regions: A consensus statement. Clin Nutr ESPEN. 2018 Apr;24:156-164. doi: 10.1016/j.clnesp.2017.11.008. Epub 2018 Jan 3.
PubMed 29576355Hoffer LJ, Bistrian BR. Nutrition in critical illness: a current conundrum. F1000Res. 2016 Oct 18;5:2531. doi: 10.12688/f1000research.9278.1. eCollection 2016.
PubMed 27803805Wray CJ, Mammen JM, Hasselgren PO. Catabolic response to stress and potential benefits of nutrition support. Nutrition. 2002 Nov-Dec;18(11-12):971-7. doi: 10.1016/s0899-9007(02)00985-1.
PubMed 12431720Lew CCH, Yandell R, Fraser RJL, Chua AP, Chong MFF, Miller M. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):744-758. doi: 10.1177/0148607115625638. Epub 2016 Feb 2.
PubMed 26838530Mogensen KM, Horkan CM, Purtle SW, Moromizato T, Rawn JD, Robinson MK, Christopher KB. Malnutrition, Critical Illness Survivors, and Postdischarge Outcomes: A Cohort Study. JPEN J Parenter Enteral Nutr. 2018 Mar;42(3):557-565. doi: 10.1177/0148607117709766. Epub 2017 Dec 18.
PubMed 28521598American Diabetes Association. Economic costs of diabetes in the U.S. In 2007. Diabetes Care. 2008 Mar;31(3):596-615. doi: 10.2337/dc08-9017.
PubMed 18308683
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Status of Critically Ill Diabetic Patients With Type 2 Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT06564168
- Acronym / sponsor ID
- Nutrition in Diabetes Mellitus
- Conditions
- Nutrition, Critical Illness, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 21 Aug 2024 (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.
- To investigate the nutritional status of patients with type 2 diabetes mellitus in the intensive care unit.
- To detect the impact of nutritional status on outcome (mortality, length of hospital stay,duration of mechanical ventilation, and need for renal replacement therapy)
Detailed description
Nutrition support in the Intensive Care Unit is very important since it has a significant impact on recovery from illness and overall outcome. Patients in the intensive care unit have a higher risk of malnutrition than patients undergoing general admission to hospitals . In critically ill patients, malnutrition may result in impaired immunological function, impaired ventilatory drive, and weakened respiratory muscles, leading to prolonged ventilatory dependence and increased infectious morbidity and mortality.
An appropriate nutritional support is indispensable to critically ill patients, who are almost at the hyper-metabolic state of their clinical condition such as trauma, sepsis, and major surgery. These critical conditions result in a disproportional release of cytokine and stress hormones that alter energy and protein metabolism and eventually lead to malnourishment.
A recent systematic review revealed the strikingly high prevalence of malnutrition in intensive care unit patients (ranged from 38% to 78%), which is associated with the patients' increased morbidity, mortality, and hospital-related cost.The increased dependency on mechanical ventilation, length of hospital stay, intensive care unit readmission, persistence of infection, and risk of hospital mortality associated with undernutrition, make it an important dilemma in the care of Intensive Care unit patients.
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood glucose.( and associated with serious complications, demand for multimodal treatment, and significant economic burden With the development of complications and hospital lengths of stay, life expectancy is worsened with diabetes, and nutritional status is generally correlated with these total outcomes.
In this research,investigators will evaluate the nutritional state in critically ill diabetic patients with type 2 diabetes mellitus, and detect the impact of poor nutritional status on out comes regarding mortality, length of hospital stay , length of mechanical ventilation, and need for renal replacement therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Crtitically ill Patients with diabetes mellitus type 2. |
| Controls | – | –All critically ill patients not Diabetes mellitus type 2. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted to the intensive care unit will be enrolled and divided into two groups. Group 1: includes all candidates with type 2 diabetes and meet the inclusion criteria and group 2: the control group includes patients without diabetes. All patients after informed consent will be subjected to: A: History. B: Examination. C: laboratory data: urea and creatinine, liver function test, and complete blood count. D: Nutritional status assessment scores: 1. Nutritional risk score (NRS)-2002. 2. Nutrition Risk in Critically ill (NUTRIC) score.
Key inclusion criteria (1 listed)
- Age above 18 years. Diabetic type ll. Admitted for more than 48 hours.
Key exclusion criteria (1 listed)
- Type 1 Diabetes Mellitus. Age under 18 years Readmission in intensive care unit. Adimssion for less than 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between Diabetes Mellitus and malnutrition in critically ill patients
Time frame: through study completion, an average of 1 year]
By using non invasive methods to find a correlation between Diabetes mellitus and malnutrition in critically ill patients by history and examination and scores of nutrition
Outcome of patients with Diabetes Mellitus admitted in intensive care unit
Time frame: through study completion, an average of 1 year]
As Diabetic patiants are more suspectible to face malnutrition in intensive care unit so non invasive methods as history, examination, score to improve outcome and decrease morbidity and mortality.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Background: PubMed 29576355Sioson MS, Martindale R, Abayadeera A, Abouchaleh N, Aditianingsih D, Bhurayanontachai R, Chiou WC, Higashibeppu N, Mat Nor MB, Osland E, Palo JE, Ramakrishnan N, Shalabi M, Tam LN, Ern Tan JJ. Nutrition therapy for critically ill patients across the Asia-Pacific and Middle East regions: A consensus statement. Clin Nutr ESPEN. 2018 Apr;24:156-164. doi: 10.1016/j.clnesp.2017.11.008. Epub 2018 Jan 3.
- Background: PubMed 27803805Hoffer LJ, Bistrian BR. Nutrition in critical illness: a current conundrum. F1000Res. 2016 Oct 18;5:2531. doi: 10.12688/f1000research.9278.1. eCollection 2016.
- Background: PubMed 12431720Wray CJ, Mammen JM, Hasselgren PO. Catabolic response to stress and potential benefits of nutrition support. Nutrition. 2002 Nov-Dec;18(11-12):971-7. doi: 10.1016/s0899-9007(02)00985-1.
- Background: PubMed 26838530Lew CCH, Yandell R, Fraser RJL, Chua AP, Chong MFF, Miller M. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):744-758. doi: 10.1177/0148607115625638. Epub 2016 Feb 2.
- Background: PubMed 28521598Mogensen KM, Horkan CM, Purtle SW, Moromizato T, Rawn JD, Robinson MK, Christopher KB. Malnutrition, Critical Illness Survivors, and Postdischarge Outcomes: A Cohort Study. JPEN J Parenter Enteral Nutr. 2018 Mar;42(3):557-565. doi: 10.1177/0148607117709766. Epub 2017 Dec 18.
- Background: PubMed 18308683American Diabetes Association. Economic costs of diabetes in the U.S. In 2007. Diabetes Care. 2008 Mar;31(3):596-615. doi: 10.2337/dc08-9017.
- Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2019. Results. Institute for Health Metrics and Evaluation. 2020Link provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition and Critical Illness, run by Assiut University.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Salwa Ahmed, Resident (01069807061, soo.ahmed.221@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between Diabetes Mellitus and malnutrition in critically ill patients (time frame: through study completion, an average of 1 year]). The study lists 2 primary outcomes in all. 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 NCT06564168, which also lists 6 linked publications.
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 26 Aug 2024.