Prevalence and Impact of Diabetes Mellitus in Hospitalized COVID-19 Patients in a Tunisian Center

NCT ID: NCT05851820

Last Updated: 2023-05-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

866 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-25

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.

Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The outbreak of the coronavirus disease 2019 (Covid-19) has become an evolving worldwide health crisis. With the rising prevalence of diabetes mellitus has come an increasing awareness of their impacts on infectious diseases, and the risk for post-infection complications and mortality from critical infections.

Objective: The objective of this study was to evaluate the prevalence and impact of diabetes mellitus on the severity and mortality of COVID-19.

Methods: Data of laboratory-confirmed hospitalized patients at the COVID-19 unit of Ibn El Jazzar University Hospital in Kairouan between September 2020 and August 2021 were analysed, in a cross-sectional study. The population was classified into two groups (COVID-19 patients with versus without diabetes). Primary outcomes were the overall length of hospital stay, the admission to the intensive care unit (ICU), and death. Association between diabetes and death was assessed in a Cox proportional hazards model.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prevalence Diabetes Mellitus Impaction COVID-19

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

diabetic patients with COVID-19

patients hospitalized for COVID-19 and were diabetic

comparison of outcomes/exposure

Intervention Type OTHER

analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.

Non-diabetic patients with COVID-19

patients hospitalized for COVID-19 and were not diabetic

comparison of outcomes/exposure

Intervention Type OTHER

analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

comparison of outcomes/exposure

analysing if diabetes mellitus have an impact on the primary outcomes: hospital stay, admission to the ICU, death.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Confirmed cases indicated the patients whose real-time reverse transcriptase-polymerase chain reaction (RT-PCR) analysis results for nasal swab specimens were positive.

Exclusion Criteria

* the investigators didn't included patients who were suspected cases, and whose the result of PCR test was negative ; Covid-19 patients admitted in other departments (Cardiology, pediatrics, obstetrics, intensive care unit, medicine, surgery department…) ; and patients with missing medical records. -
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sana Rouis

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sana Rouis

Assistant professor in Infectious Diseases

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

sana rouis, MD

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Sousse

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kairouan

Kairouan, , Tunisia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Tunisia

References

Explore related publications, articles, or registry entries linked to this study.

Apicella M, Campopiano MC, Mantuano M, Mazoni L, Coppelli A, Del Prato S. COVID-19 in people with diabetes: understanding the reasons for worse outcomes. Lancet Diabetes Endocrinol. 2020 Sep;8(9):782-792. doi: 10.1016/S2213-8587(20)30238-2. Epub 2020 Jul 17.

Reference Type BACKGROUND
PMID: 32687793 (View on PubMed)

Yang JK, Feng Y, Yuan MY, Yuan SY, Fu HJ, Wu BY, Sun GZ, Yang GR, Zhang XL, Wang L, Xu X, Xu XP, Chan JC. Plasma glucose levels and diabetes are independent predictors for mortality and morbidity in patients with SARS. Diabet Med. 2006 Jun;23(6):623-8. doi: 10.1111/j.1464-5491.2006.01861.x.

Reference Type BACKGROUND
PMID: 16759303 (View on PubMed)

Wu J, Zhang J, Sun X, Wang L, Xu Y, Zhang Y, Liu X, Dong C. Influence of diabetes mellitus on the severity and fatality of SARS-CoV-2 (COVID-19) infection. Diabetes Obes Metab. 2020 Oct;22(10):1907-1914. doi: 10.1111/dom.14105. Epub 2020 Jul 7.

Reference Type BACKGROUND
PMID: 32496012 (View on PubMed)

Al-Salameh A, Lanoix JP, Bennis Y, Andrejak C, Brochot E, Deschasse G, Dupont H, Goeb V, Jaureguy M, Lion S, Maizel J, Moyet J, Vaysse B, Desailloud R, Ganry O, Schmit JL, Lalau JD. Characteristics and outcomes of COVID-19 in hospitalized patients with and without diabetes. Diabetes Metab Res Rev. 2021 Mar;37(3):e3388. doi: 10.1002/dmrr.3388. Epub 2020 Aug 18.

Reference Type BACKGROUND
PMID: 32683744 (View on PubMed)

Wang B, Li R, Lu Z, Huang Y. Does comorbidity increase the risk of patients with COVID-19: evidence from meta-analysis. Aging (Albany NY). 2020 Apr 8;12(7):6049-6057. doi: 10.18632/aging.103000. Epub 2020 Apr 8.

Reference Type BACKGROUND
PMID: 32267833 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SRouis

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.