Glycemic Gap Versus Admission Plasma Glucose Level As Predictors of ICU Out Comes in Type 2 Diabetic Patients With Acute Heart Failure

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04922099
Collaborator
(none)
132
19

Study Details

Study Description

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

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
132 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Glycemic Gap Versus Admission Plasma Glucose Level As Predictors of ICU Out Comes in Type 2 Diabetic Patients With Acute Heart Failure
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jan 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure [through study completion an avarage 1 year]

    Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fatema Medhat Ahmed, resident doctor, Assiut University
ClinicalTrials.gov Identifier:
NCT04922099
Other Study ID Numbers:
  • Glycemic gap
First Posted:
Jun 10, 2021
Last Update Posted:
Jun 10, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2021