Covid19COVID-19-DM2NCT04591704
The Effect of Diabetes Mellitus on the Prognosis of Patients With COVID-19
An observational study of Covid19 and Diabetes Mellitus, run by Uşak University at 1 site in Turkey (Türkiye).
Trial summary
All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study. The patients will be divided into two groups, as diabetics and non-diabetics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19, Diabetes Mellitus
- What is being tested?
- hospitalisation, necessity of ICU, mortality rate, lung involvement
- How many people
- 2,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2020to 1 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
Study population: All patients aged between 18-80 years, diagnosed and hospitalised for COVID-19 will be enrolled in to the study
Who may be able to join
- Patients hospitalized for COVID-19
Who cannot join
- Patients with known malignancy
- Pregnant patients
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Usak University Training and Research Hospital
Uşak, 64200
Cevdet Duran, 02762212121, drcduran@gmail.com
About this study
Official title: The Effect of Diabetes Mellitus on the Morbidity and Mortality Rates in Patients With COVID-19
All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.
The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.
Read the detailed description
All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.
The patients will be divided into two groups, as diabetics and non-diabetics. The diagnosis of diabetes mellitus will be extracted from the medical records and medical history of the patients hospitalised with COVID-19.
The COVID-19 patients medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.
- Conditions
- Covid19, Diabetes Mellitus
- Being tested
- hospitalisation, necessity of ICU, mortality rate, lung involvement
- Medical subject headings
- COVID-19, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hospitalisation, necessity of ICU, mortality rate, lung involvementOther
hospitalisation, necessity of ICU, mortality rate, lung involvement
| Study group | Role | What they receive |
|---|---|---|
| Diabetic groups | COVID-19 patients with diabetes mellitus Receives: Other: hospitalisation, necessity of ICU, mortality rate, lung involvement | |
| Control groups | COVID-19 patients without diabetes mellitus Receives: Other: hospitalisation, necessity of ICU, mortality rate, lung involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Hospitalisation
The time between admission to hospital and discharge
Measured: 1 year
The need for ICU
The admission of hospitalized patients to the intensive care unit.
Measured: 1 year
Mortality
Mortality rates of patients
Measured: 1 year
Lung involvement
The presence of lung involvement on thorax CT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start20 Mar 2020
- Primary completion15 Oct 2020
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cevdet Duran, Principal investigator, Uşak Üniversitesi Tıp fak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591704
- Sponsor's protocol ID
- UU-DM003
- Acronym
- COVID-19-DM2
- Status last verified
- May 2021
- First submitted
- 16 Oct 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Diabetes Mellitus on the Morbidity and Mortality Rates in Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04591704
- Acronym / sponsor ID
- COVID-19-DM2 / UU-DM003
- Conditions
- Covid19, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 15 Oct 2020 (actual)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.
The patients will be divided into two groups, as diabetics and non-diabetics. The COVID-19 patients' medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.
Detailed description
All hospitalised patients with COVID-19 who have positive RT-PCR for SARS-COV-2 will be included in the study.
The patients will be divided into two groups, as diabetics and non-diabetics. The diagnosis of diabetes mellitus will be extracted from the medical records and medical history of the patients hospitalised with COVID-19.
The COVID-19 patients medical records will be evaluated and compared in terms of the duration of hospitalization, the presence of lung involvement in Computerised Tomography, the need for intensive care unit and mortality rates in patients with and without diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic groups | – | Other: hospitalisation, necessity of ICU, mortality rate, lung involvementCOVID-19 patients with diabetes mellitus |
| Control groups | – | Other: hospitalisation, necessity of ICU, mortality rate, lung involvementCOVID-19 patients without diabetes mellitus |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients aged between 18-80 years, diagnosed and hospitalised for COVID-19 will be enrolled in to the study
Key inclusion criteria (1 listed)
- Patients hospitalized for COVID-19
Key exclusion criteria (2 listed)
- Patients with known malignancy
- Pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hospitalisation, necessity of ICU, mortality rate, lung involvementhospitalisation, necessity of ICU, mortality rate, lung involvement | Other | Control groups, Diabetic groups |
Primary outcome
Duration of Hospitalisation
Time frame: 1 year
The time between admission to hospital and discharge
The need for ICU
Time frame: 1 year
The admission of hospitalized patients to the intensive care unit.
Mortality
Time frame: 1 year
Mortality rates of patients
Lung involvement
Time frame: 1 year
The presence of lung involvement on thorax CT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cevdet Duran principal investigator
Uşak Üniversitesi Tıp fak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Diabetes Mellitus, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cevdet Duran (02762212121, drcduran@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Hospitalisation (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.