Clinical trial NCT04922099: Glycemic Gap Versus Admission Plasma Glucose Level As Predictors of ICU Out Comes in Type 2 Diabetic Patients With Acute Heart Failure
Official title: Glycemic Gap Versus Admission Plasma Glucose Level As Predictors of ICU Out Comes in Type 2 Diabetic Patients With Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Assess the Relation Between Glycemic Gab and Adverse Clinical Outcomes in Diabetic Patients Who Hospitalized With Heart Failure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All diabetic patients admitted to ICU of internal medicine department from October 2020 to November 2021 by heart failure

Brief summary: assess the relation between glycemic gab and adverse clinical outcomes in diabetic patients who hospitalized with heart failure

Detailed description: Hyperglycemia is a common problem in patients wi9non-diabetic patients but not in patients with diabetes . The relationship between admission hyperglycemia and mortality in diabetic patients with AHF or critical illness remains controversial . Those discrepancies could be partly attributed to long-term glycemic control in diabetic patients.

Critical illness can induce stress-induced hyperglycemia (SIH), which results from the excess release of counter-regulatory hormones and anti-inflammatory cytokines, leading to augmented gluconeogenesis and insulin resistance.

In diabetic patients with acute illness, the phenomenon of admission hyperglycemia could be connected with acute physiological stress, poorer glycemic controls, or a combination of both . It is necessary to think about background glycemic control when exploring the relationships between admissions Hyperglycemia and clinical outcomes. Recent studies have shown that hemoglobin A1c (HbA1c)-based adjusted glycemic variables, including glycemic gap and stress hyperglycemia ratio, were linked to severity of disease and unfavorable prognosis in diabetic patients with some infectious diseases, cardiovascular diseases and clinical illness

Eligibility criteria: Inclusion Criteria:

* All diabetic patients admitted to ICU of internal medicine department from October 2020 to November 2021 by heart failure

Exclusion Criteria:

* Age ≤18 years.

  1. Hypoglycemia (plasma glucose \<70 mg/dL) at initial presentation.
  2. An admission diagnosis of diabetic ketoacidosis or hyperosmolar hyperglycemic state.
  3. Patients with hemoglobin variants (e.g., sickle cell anemia, thalassemia) or with hematologic conditions (e.g., hemolytic anemia) that could interfere with the accuracy of the HbA1c assay.

Primary outcomes:
measure: Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure
timeFrame: through study completion an avarage 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Lazzeri C, Valente S, Chiostri M, D'Alfonso MG, Spini V, Angelotti P, Gensini GF. Admission Glycaemia and Acute Insulin Resistance in Heart Failure Complicating Acute Coronary Syndrome. Heart Lung Circ. 2015 Nov;24(11):1074-80. doi: 10.1016/j.hlc.2015.04.171. Epub 2015 May 16.
citation: de Miguel-Yanes JM, Gonzalo-Hernando C, Munoz-Rivas N, Mendez-Bailon M, Cava-Valenciano F, Torres-Macho J. First plasma glucose value after urgent admission and in-hospital mortality in acutely decompensated heart failure. Heart Lung. 2015 Mar-Apr;44(2):137-40. doi: 10.1016/j.hrtlng.2014.11.006. Epub 2014 Dec 18.
citation: Dungan KM, Braithwaite SS, Preiser JC. Stress hyperglycaemia. Lancet. 2009 May 23;373(9677):1798-807. doi: 10.1016/S0140-6736(09)60553-5.
citation: Yang CJ, Liao WI, Wang JC, Tsai CL, Lee JT, Peng GS, Lee CH, Hsu CW, Tsai SH. Usefulness of glycated hemoglobin A1c-based adjusted glycemic variables in diabetic patients presenting with acute ischemic stroke. Am J Emerg Med. 2017 Sep;35(9):1240-1246. doi: 10.1016/j.ajem.2017.03.049. Epub 2017 Mar 22.