Clinical trial NCT06564168: Nutritional Status of Critically Ill Diabetic Patients
Official title: Nutritional Status of Critically Ill Diabetic Patients With Type 2 Diabetes Mellitus.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Nutrition
Critical Illness
Diabetes Mellitus, Type 2
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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)

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.

Eligibility criteria: Inclusion Criteria:

Age above 18 years. Diabetic type ll. Admitted for more than 48 hours.

Exclusion Criteria:

Type 1 Diabetes Mellitus. Age under 18 years Readmission in intensive care unit. Adimssion for less than 48 hours

Primary outcomes:
measure: Correlation between Diabetes Mellitus and malnutrition in critically ill patients
timeFrame: through study completion, an average of 1 year]
measure: Outcome of patients with Diabetes Mellitus admitted in intensive care unit
timeFrame: through study completion, an average of 1 year]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Hoffer LJ, Bistrian BR. Nutrition in critical illness: a current conundrum. F1000Res. 2016 Oct 18;5:2531. doi: 10.12688/f1000research.9278.1. eCollection 2016.
citation: Wray 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.
citation: Lew 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.
citation: Mogensen 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.
citation: American 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.