An investigation of malnutrition, obesity, diabetes, high blood pressure and severe COVID-19 in Italy
| ISRCTN | ISRCTN27707558 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27707558 |
| Secondary identifying numbers | 02/2020 |
- Submission date
- 25/12/2020
- Registration date
- 30/12/2020
- Last edited
- 31/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English Summary
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
The prevalence in the general population of obesity, diabetes, hypertension (high blood pressure) and malnutrition (poor diet) is high, therefore it is useful to investigate the clinical significance when these conditions are present in patients with COVID-19.
Who can participate?
Patients admitted to different Italian hospitals for serious COVID-19 disease.
What does the study involve?
The study will examine the medical records of patients with serious COVID-19 to find health and lifestyle factors that are related to severe COVD-19. If the records do not contain all the required information the participant may have a telephone interview to gather missing information.
What are the possible benefits and risks of participating?
The benefit of participating is helping with the research. This study could provide useful information for the prognosis and treatment of this disease and could promote better management of the disease. There are no risks associated with participating.
Where is the study run from?
University of Palermo (Italy).
When is the study starting and how long is it expected to run for?
December 2020 to June 2021.
Who is funding the study?
University of Palermo (Italy)
Who is the main contact?
Prof. Silvio Buscemi, MD, silvio.buscemi@unipa.it
Contact information
Scientific
University of Palermo - PROMISE department
Unit of Clinical Nutrition; AOU Policlinico "P. Giaccone"
Piazza delle Cliniche, 2
Palermo
90127
Italy
 ORCID ID |
0000-0003-0730-7649 |
|---|---|
| Phone | +39 91 6552251 |
| silvio.buscemi@unipa.it |
Study information
| Study design | Longitudinal observational retrospective multicenter study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | Malnutrition, obesity, diabetes, hypertension and severe COVID-19 in Italy |
| Study acronym | MODIeCOSe in Italia |
| Study hypothesis | The prevalence in the general population of obesity, diabetes, hypertension and malnutrition is high. It is useful to investigate the association of these diseases with severe COVID-19 to improve prognosis and treatment in the hospital environment. |
| Ethics approval(s) | Approved 18/12/2020, Palermo 1 Ethics Committee (AOU Policlinico "P. Giaccone"; via del vespro 129 -90127 Palermo, Italy; +39 91 6555210/5211; bioetica@policlinico.pa.it), ref: 11/2020 |
| Condition | To investigate the association between obesity, diabetes, hypertension and malnutrition with severe COVID-19 outcome (SARS-CoV-2 infection) in hospital settings |
| Intervention | Patients must fulfil the inclusion criteria for entry. Data will be extracted from the medical records and databases of each center. In the case of patients who have previously given written consent to be contacted, the evaluation/completion of any missing data can be ensured through a telephone interview with the patient or caregiver. Data will be made anonymous and identified through a code. The code will be linked to each patient's medical record in a guarded list of each center. The data will flow into a single Excel database at the main center. |
| Intervention type | Other |
| Primary outcome measure | Measured using patient records (and a telephone interview if required) at a single time point: 1. Demographics 1.1. Age 1.2. Ethnicity 1.3. Current or previous work activity 1.4. Self-sufficient patient (yes/no) 1.5. In a nursing home (yes/no) 1.6. Caregiver (yes/no) 2. Hospitalisation and outcome 2.1. Duration of hospitalization (days) 2.2. Transferred to resuscitation (yes/no) 2.3. Recovery (yes/no) 3. Vaccinated for influenza or pneumococcus (yes/no) 4. Anthropometric data 4.1. Height (cm) 4.2. Weight (kg) 4.3. Waist circumference (cm) 5. Medication history before admission 6. Hematology at entry and near discharge 6.1. Leukocytes (x10(9)/L) 6.2. Red blood cells (x10(12)/L) 6.3. Hemoglobin - HB (g/dl) 6.4. Hematocrit - Hct (%) 6.5. MCV (f/L) 6.6. Platelets (x10(9)/L) 6.7. Lymphocytes (x10(9)/L) 6.8. Neutrophils (x10(9)/L) 7. Lab values at entry and near discharge 7.1. Blood glucose (mg/dl) 7.2. HbA1c (%) 7.3. Creatinine (mg/ml) 7.4. Total cholesterol (mg/dl) 7.5. HDL cholesterol (mg/dl) 7.6. Triglycerides (mg/dl) 7.7. ALT (U/L) 7.8. AST (U/L) 7.9. GGT (U/L) 7.10. Albunemia (%) 7.11. Total proteins (g/dl) 7.12. eGFR IL-6 (pg/ml) 7.13. C-reactive protein (mg/dl) 7.14. CK (mg/dl) 7.15. LDH (U/L) 7.16. Ferritin (ng/ml) 8. Blood gas values at entry and near discharge 8.1. PaO2 8.2. PaCO2 8.3. FiO2 8.4. PH 8.5. Lactates 8.6. HCO3- SO2 8.7. Oxygen therapy (y/n) 8.8. PEEP 9. Therapy during stay 9.1. Paracetamol 9.2. Cortisone 9.3. Antibiotic (Macrolide [azithromycin], cephalosporin, quinolone) 9.4. Heparin 9.5. Chloroquine/Hydroxychloroquine 9.6. Cholecalciferol 9.7. Artificial nutrition 9.8. Other 10. Previous pathologies 10.1. Diabetes mellitus 10.2. Arterial hypertension 10.3. Ischemic heart disease 10.4. Chronic heart failure 10.5. Smoking 10.6. Atrial fibrillation 10.7. Neoplasms 10.8. Chronic obstructive pulmonary disease 10.9. Bronchial asthma 10.10. Chronic renal failure 10.11. Stroke 10.12. Pulmonary embolism 10.13. Congenital heart disease 10.14. Other |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 18/12/2020 |
| Overall study end date | 30/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | >2,000 |
| Participant inclusion criteria | 1. Hospitalized patients 2. Proven COVID-19 disease 3. Aged 18 and above |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/02/2020 |
| Recruitment end date | 31/03/2021 |
Locations
Countries of recruitment
- Italy
Study participating centres
Unit of Clinical Nutrition
AOU Policlinico “P. Giaccone”
Piazza delle Cliniche, 2
Palermo
90127
Italy
Nutrizione Clinica e Obesità
Via Ravona
San Fermo della Battaglia (CO)
22042
Italy
Piazza Edmondo Malan, 2
San Donato Milanese (MI)
20097
Italy
Azienda Ospedaliera Università Padova
Via Giustiniani, 2
Padova (PD)
35128
Italy
Azienda Ospedaliero-Universitaria Pisana
Via Paradisa, 2
Pisa
56124
Italy
Azienda Ospedaliero-Universitaria Pisana
Via Paradisa, 2
Pisa
56124
Italy
Via Montpellier, 1
Roma
00133
Italy
UOC Diabetologia Universitaria Ospedale Santa Maria Goretti
Via Guido Reni
Latina
04100
Italy
Viale Tommaso Campanella, 115
Catanzaro
88100
Italy
Via Palermo, 636
Catania
95122
Italy
Medicina interna COVID, AOU Policlinico “P. Giaccone”
Via delle Cliniche, 2
Palermo
90127
Italy
Malattie Infettive, AOU Policlinico “P. Giaccone”
Via delle Cliniche, 2
Palermo
90127
Italy
Pneumologia COVID, AOU Policlinico “P. Giaccone”
Via delle Cliniche, 2
Palermo
90127
Italy
P.zza Nicola Leotta, 4
Palermo
90127
Italy
Contrada Sant Elia
Petralia Sottana (PA)
90027
Italy
Sponsor information
University/education
Dipartimento PROMISE
Piazza delle Cliniche, 2
Palermo
90127
Italy
| Phone | +39 91 6552250 |
|---|---|
| dipartimento.promise@unipa.it | |
| Website | https://www.unipa.it/dipartimenti/promise |
"ROR" |
https://ror.org/044k9ta02 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. Data will become available soon after the first publication and for 5 years for public authorities and researchers who request it, explaining the reasons and uses that will be made of it, meaning that they cannot be used to be published unless otherwise authorized) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 04/12/2020 | 31/12/2020 | No | No |
Additional files
- ISRCTN27707558_PROTOCOL_04Dec2020.pdf
- uploaded 31/12/2020
Editorial Notes
NHW 31/12/2020: Uploaded protocol (not peer reviewed) Version n/a, 04 December 2020.
30/12/2020: Trial’s existence confirmed by AOU Policlinico "P. Giaccone"
