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

17 listopada 2020 zaktualizowane przez: 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.

Przegląd badań

Status

Nieznany

Warunki

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Oczekiwany)

1050

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat do 99 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

COVID 19 positive patients with or without diabetes

Opis

Inclusion Criteria:

>18 yrs male or female
COVID-19 positive

Exclusion Criteria:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Liczba grup / kohort

Kohorty i interwencje

Grupa / Kohorta
COVID 19 positive patients without diabetes
COVID 19 positive patients with diabetes

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
Severity of COVID 19 among people with and without diabetes Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
Number of patients who were in ICU Ramy czasowe: Up to 1 month	Number of patients who were in ICU	Up to 1 month
Number of patients who had tracheal intubation Ramy czasowe: Up to 1 month	Number of patients who had tracheal intubation	Up to 1 month
Number of patients who had respiratory complication Ramy czasowe: Up to 1 month	Number of patients who had respiratory complication	Up to 1 month
Number of death Ramy czasowe: Up to 1 month	Number of death	Up to 1 month
Correlation of BMI with complications, tracheal intubation and mortality Ramy czasowe: Up to 1 month	Correlation of BMI with complications, tracheal intubation and mortality	Up to 1 month
Length of hospital stay Ramy czasowe: Up to 1 month	Length of hospital stay	Up to 1 month

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

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

Śledczy

Główny śledczy: Ambady Ramachandran, M.D,PhD,DSc, President

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Oczekiwany)

16 listopada 2020

Zakończenie podstawowe (Oczekiwany)

16 lutego 2021

Ukończenie studiów (Oczekiwany)

16 maja 2021

Daty rejestracji na studia

Pierwszy przesłany

15 listopada 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości

17 listopada 2020

Pierwszy wysłany (Rzeczywisty)

18 listopada 2020

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)