Nutritional Status of Critically Ill Diabetic Patients

NCT ID: NCT06564168

Last Updated: 2024-08-26

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

NOT_YET_RECRUITING

Total Enrollment

430 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-03-31

Brief Summary

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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

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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

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Nutrition Critical Illness Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Crtitically ill Patients with diabetes mellitus type 2.

No interventions assigned to this group

Controls

All critically ill patients not Diabetes mellitus type 2.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Salwa Ahmed Mohammed Ali

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Salwa Ahmed, Resident

Role: CONTACT

01069807061

Taghreed Sayed, Ass.Prof.

Role: CONTACT

01003651135

References

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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.

Reference Type BACKGROUND
PMID: 29576355 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27803805 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12431720 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26838530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28521598 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18308683 (View on PubMed)

Related Links

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https://vizhub.healthdata.org/gbd-results/).

Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2019. Results. Institute for Health Metrics and Evaluation. 2020

Other Identifiers

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Nutrition in Diabetes Mellitus

Identifier Type: -

Identifier Source: org_study_id

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