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The Severity of COVID 19 in Diabetes and Non-diabetes Patients (COVID19)

17. listopadu 2020 aktualizováno: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Study on Characteristics and Prognosis of Diabetes and Non Diabetes Patients With COVID 19 Among Southern Indian Population

There were 83,85,440 confirmed cases of COVID-19 worldwide with a mortality rate of 5.4% according to the situation report of the World Health Organisation on June 19, 2020. In India there were 3,95,048 confirmed cases of COVID-19 with a mortality rate of 3.3%. In Tamil Nadu there were 54,449 confirmed cases of COVID-19 with a mortality rate of 1.2% according to the report of Ministry of Health and Family Welfare, Government of India on June 19, 2020.

COVID-19 infection is a double challenge for people with diabetes. India has a large number of persons with diabetes (more than 77 million). Recent studies have reported rising prevalence both in the urban and rural populations. The incidence of type 2 diabetes (T2D) also shows an increasing trend in the last few decades. Mortality seems to be threefold higher in people with diabetes when COVD-19 coexists when compared with mortality due to COVID-19 without comorbidities.

Yang et al noted that among 52 intensive care patients who had COVID 19 infection, 22% had diabetes among the non-survivors. In a study of 173 patients with severe disease, 16.2% had diabetes, and in another study of 140 hospitalized patients, 12% had diabetes. Li et al compared intensive care and non-intensive care patients who had COVID-19. They showed a twofold increase in the incidence of diabetes in intensive care patients.

In addition to diabetes; the other common co-morbidities present in COVID 19 patients were hypertension (20%), cardiovascular disease (16%), and lung disease (6%). In this context, patients with diabetes have been listed as people with higher severity for COVID-19 by several health authorities. However, precise data regarding patients with and without diabetes having COVID-19 infection are still lacking. Moreover, the relationship between diabetes and the severity of COVID-19 remains unknown. In this study, we intend to identify the disease severity and mortality in people with and without diabetes admitted for COVID-19 in southern India.

Přehled studie

Postavení

Neznámý

Podmínky

Detailní popis

The following data from a person tested positive for COVID 19 and hospitalized will be collected. Patient's anthropometry (height in cms, weight in kgs and body mass index in kg/m2), blood pressure, symptoms of COVID-19 (fever, fatigue, cough, cephalalgia, dyspnoea, rhinitis, pharyngeal symptoms, ageusia, anosmia, digestive disorders), history of smoking, hypertension, dyslipidemia, microvascular (retinopathy, nephropathy and neuropathy), macrovascular (coronary artery disease, cerebrovascular disease and peripheral vascular disease) complications and other co morbid conditions will be recorded. Fasting blood glucose, HbA1c and any other relevant investigations if available and treatment for COVID-19 and other co morbid conditions will be recorded.

Details of patients developing new symptoms, shifted to ICU, intubated or died during the course of treatment will be recorded. Appearance of any complication during the stay at hospital will be recorded. The changes in the treatment pattern during the course of the disease will also be noted.

The registry will be fully anonymised and statistician will have no access to patients' personal identifiers. All "investigators" will have to register before entering data in the registry. Data about clinical observations for the individual patient will be entered by clinicians or by authorised research personnel of the care team in the web registry.

Patients' name, date of birth, date of death, residential postal code, hospital number will be fully anonymised at source. In no circumstances, patients' identifiable data be available to anyone outside their own care teams or authorised local administration/research personnel. Patient data will not at any stage will be in identifiable form by the registry managers. The data to be collected from the patients are mentioned in the visit chart.

Typ studie

Pozorovací

Zápis (Očekávaný)

1050

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Indie
- Tamil Nadu
  - Chennai, Tamil Nadu, Indie, 600014
    - Orthomed Hospital
  - Chennai, Tamil Nadu, Indie, 600024
    - Medway Hospital
  - Chennai, Tamil Nadu, Indie, 600035
    - Venkateswara Hospital
  - Chennai, Tamil Nadu, Indie, 600044
    - Dr. Rela Institute & Medical Center

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 99 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

COVID 19 positive patients with or without diabetes

Popis

Inclusion Criteria:

>18 yrs male or female
COVID-19 positive

Exclusion Criteria:

COVID 19 Negative
New-onset Diabetes with covid-19 infection

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Počet skupin / kohort

Kohorty a intervence

Skupina / kohorta
COVID 19 positive patients without diabetes
COVID 19 positive patients with diabetes

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Severity of COVID 19 among people with and without diabetes Časové okno: Up to 1 month	To identify the disease severity and outcome among people with and without diabetes hospitalized for COVID 19 virus infection	Up to 1 month

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Number of patients who were in ICU Časové okno: Up to 1 month	Number of patients who were in ICU	Up to 1 month
Number of patients who had tracheal intubation Časové okno: Up to 1 month	Number of patients who had tracheal intubation	Up to 1 month
Number of patients who had respiratory complication Časové okno: Up to 1 month	Number of patients who had respiratory complication	Up to 1 month
Number of death Časové okno: Up to 1 month	Number of death	Up to 1 month
Correlation of BMI with complications, tracheal intubation and mortality Časové okno: Up to 1 month	Correlation of BMI with complications, tracheal intubation and mortality	Up to 1 month
Length of hospital stay Časové okno: Up to 1 month	Length of hospital stay	Up to 1 month

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

Vyšetřovatelé

Vrchní vyšetřovatel: Ambady Ramachandran, M.D,PhD,DSc, President

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Očekávaný)

16. listopadu 2020

Primární dokončení (Očekávaný)

16. února 2021

Dokončení studie (Očekávaný)

16. května 2021

Termíny zápisu do studia

První předloženo

15. listopadu 2020

První předloženo, které splnilo kritéria kontroly kvality

17. listopadu 2020

První zveřejněno (Aktuální)

18. listopadu 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)