- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04382794
Sitagliptin Treatment in Diabetic COVID-19 Positive Patients (SIDIACO-RETRO')
Sitagliptin Treatment in Diabetic COVID-19 Positive Patients: Retrospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
An observational, retrospective-case control, multi-center study is proposed to evaluate any effects of Sitagliptin on clinical, laboratory and instrumental parameters in the course of hospitalization for COVID-19. The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study. The evaluation will be performed by comparing the parameters of COVID-19 positive diabetic patients treated with Sitagliptin with those of a group of COVID-19 positive diabetic patients not treated with Sitagliptin. All diabetic subjects treated with Sitagliptin (100 mg / day, 50 mg / day or 25 mg / day) and all diabetic subjects not treated with Sitagliptin, eligible for inclusion / exclusion criteria, will be included in the analysis.
The clinical data of patients that will be collected anonymously during hospitalization will include: smoking habit, remote medical history aimed at assessing the presence of comorbidities (atrial fibrillation, heart failure, hypertension, arterial hypertension, chronic obstructive pulmonary disease, other lung disease, chronic renal failure, decay cognitive, Parkinson's disease, autoimmune diseases), pharmacological history (treatment introduced during hospitalization for COVID-19, respiratory failure or other complications; use of ACE-inhibitors, sartans, calcium channel blockers, diuretics, antiarrhythmics, beta blockers, anti-aggregants, anticoagulants, neuroleptics ). Anthropometric parameters including blood pressure measurement and BMI will also be collected.
For all patients, the following data will be collected at the baseline (first data available upon entry into the hospitalization regime) and upon discharge:
- Clinical picture and symptoms (presence of cough, body temperature, respiratory rate, need for ventilatory support, duration of ventilatory support in days, duration of oxygen therapy in day, duration of hospitalization in Intensive Care Unit in days, total length of stay in days, blood gas parameters, PaO2 / FiO2 ratio, oxygen saturation by pulse oximeter)
- Routine blood chemistry tests performed in hospitalization (e.g. glycemia, reactive protein C, blood count with formula, erythrocyte sedimentation rate, blood gas analysis, LDH, inflammation indices).
- Instrumental exams (chest x-ray)
- glycated hemoglobin
- Serum creatinine and Estimated Glomerular Filtration Rate (estimated with CKD-EPI)
- Presence of specific comorbidities for diabetes
- Average daily blood sugar levels (from capillary blood)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Bergamo, Italy, 24127
- Papa Giovanni XXIII Hospital
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Mestre, Italy, 30174
- Ospedale dell'Angelo, Venezia-Mestre
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Milan, Italy, 20089
- Humanitas Hospital
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Pavia, Italy, 27100
- IRCCS Policlinico S. Matteo
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Pavia, Italy, 20100
- University of Pavia
-
-
MI
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Milan, MI, Italy, 20157
- ASST FBF-Sacco P.O. Sacco
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosis of type 2 diabetes, according to ADA 2020 criteria
- Diagnosis of COVID-19 (positive SARS-COV2 RNA buffer) with pneumonia, with or without an increase in inflammation indexes, with or without respiratory failure
Exclusion Criteria:
- Pregnancy
- Type 1 diabetes
- Presence of other acute infections in place
- Presence of serious diseases or conditions that make the patient unsuitable for the study
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
DMT2 COVID19 positive patients treated with Sitagliptin
The anonymous data relating to the clinical, laboratory and instrumental parameters of patients hospitalized for COVID-19 and suffering from type 2 diabetes treated with Sitagliptin will be extracted from the medical records currently in use in the centers participating in the study.
The data will be anonymous and not attributable to individual subjects
|
Evaluation of clinical, laboratory and instrumental parameters of diabetic patients during hospitalization for COVID-19.
The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study
|
DMT2 COVID19 positive patients not treated with Sitagliptin
The anonymous data relating to the clinical, laboratory and instrumental parameters of patients hospitalized for COVID-19 and suffering from type 2 diabetes not treated with Sitagliptin will be extracted from the medical records currently in use in the centers participating in the study.
The data will be anonymous and not attributable to individual subjects
|
Evaluation of clinical, laboratory and instrumental parameters of diabetic patients during hospitalization for COVID-19.
The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical parameter of acute lung disease
Time Frame: 1 month
|
Clinical evaluation of physiological parameter "cough" associated with acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Clinical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the clinical parameter "oxygen saturation by the use of a pulse oximeter" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Clinical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the clinical parameter "body temperature" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Clinical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the clinical parameter "PaO2/FiO2" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Clinical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the clinical parameter "respiratory rate" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Clinical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the clinical parameter "need for ventilator support" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Clinical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the clinical parameter "duration in days of ventilator support, duration in days of oxygen therapy, duration in days of hospitalization, duration in days in the Intensive Care Unit, total length of stay in hospital" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Death
Time Frame: 1 month
|
Death of the patient during hospitalization due to COVID19
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the biochemical parameter "reactive C protein" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Biochemical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the biochemical parameter "blood count with formula" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Biochemical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the biochemical parameter "erythrocyte sedimentation rate" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Biochemical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the biochemical parameter "blood gas analysis" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Biochemical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the biochemical parameter "LDH" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Biochemical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the biochemical parameter "fasting blood glucose" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Clinical parameter of acute lung disease
Time Frame: 1 month
|
Variation of the clinical parameter "chest X ray" of acute lung disease from the beginning of the study to the end of the study
|
1 month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Paolo Fiorina, MD, PhD, ASST FBF Sacco
Publications and helpful links
General Publications
- Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26.
- 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.
- Perlman S, Azhar EI, Memish ZA, Hui DS, Zumla A. Confronting the persisting threat of the Middle East respiratory syndrome to global health security. Lancet Infect Dis. 2020 Feb;20(2):158-160. doi: 10.1016/S1473-3099(19)30347-0. Epub 2019 Jul 3. No abstract available.
- Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Apr 11;395(10231):1225-1228. doi: 10.1016/S0140-6736(20)30627-9. Epub 2020 Mar 13.
- Zou H, Zhu N, Li S. The emerging role of dipeptidyl-peptidase-4 as a therapeutic target in lung disease. Expert Opin Ther Targets. 2020 Feb;24(2):147-153. doi: 10.1080/14728222.2020.1721468. Epub 2020 Jan 31.
- Meyerholz DK, Lambertz AM, McCray PB Jr. Dipeptidyl Peptidase 4 Distribution in the Human Respiratory Tract: Implications for the Middle East Respiratory Syndrome. Am J Pathol. 2016 Jan;186(1):78-86. doi: 10.1016/j.ajpath.2015.09.014. Epub 2015 Nov 18.
- Bolla AM, Loretelli C, Montefusco L, Finzi G, Abdi R, Ben Nasr M, Lunati ME, Pastore I, Bonventre JV, Nebuloni M, Rusconi S, Santus P, Zuccotti G, Galli M, D'Addio F, Fiorina P. Inflammation and vascular dysfunction: The negative synergistic combination of diabetes and COVID-19. Diabetes Metab Res Rev. 2022 Oct;38(7):e3565. doi: 10.1002/dmrr.3565. Epub 2022 Jul 22.
- Lambeir AM, Durinx C, Scharpe S, De Meester I. Dipeptidyl-peptidase IV from bench to bedside: an update on structural properties, functions, and clinical aspects of the enzyme DPP IV. Crit Rev Clin Lab Sci. 2003 Jun;40(3):209-94. doi: 10.1080/713609354.
- Schade J, Stephan M, Schmiedl A, Wagner L, Niestroj AJ, Demuth HU, Frerker N, Klemann C, Raber KA, Pabst R, von Horsten S. Regulation of expression and function of dipeptidyl peptidase 4 (DP4), DP8/9, and DP10 in allergic responses of the lung in rats. J Histochem Cytochem. 2008 Feb;56(2):147-55. doi: 10.1369/jhc.7A7319.2007. Epub 2007 Oct 29.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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