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

June 9, 2021 updated by: Fatema Medhat Ahmed, Assiut University
assess the relation between glycemic gab and adverse clinical outcomes in diabetic patients who hospitalized with heart failure

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

132

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic gap versus admission plasma glucose level As predictors of ICU out comes in type 2 diabetic patients with acute heart failure
Time Frame: 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
through study completion an avarage 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 9, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Glycemic gap

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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