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

17 novembre 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

1050

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 99 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

COVID 19 positive patients with or without diabetes

Descrizione

Inclusion Criteria:

>18 yrs male or female
COVID-19 positive

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
COVID 19 positive patients without diabetes
COVID 19 positive patients with diabetes

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Severity of COVID 19 among people with and without diabetes Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Number of patients who were in ICU Lasso di tempo: Up to 1 month	Number of patients who were in ICU	Up to 1 month
Number of patients who had tracheal intubation Lasso di tempo: Up to 1 month	Number of patients who had tracheal intubation	Up to 1 month
Number of patients who had respiratory complication Lasso di tempo: Up to 1 month	Number of patients who had respiratory complication	Up to 1 month
Number of death Lasso di tempo: Up to 1 month	Number of death	Up to 1 month
Correlation of BMI with complications, tracheal intubation and mortality Lasso di tempo: Up to 1 month	Correlation of BMI with complications, tracheal intubation and mortality	Up to 1 month
Length of hospital stay Lasso di tempo: Up to 1 month	Length of hospital stay	Up to 1 month

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

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

Investigatori

Investigatore principale: Ambady Ramachandran, M.D,PhD,DSc, President

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

16 novembre 2020

Completamento primario (Anticipato)

16 febbraio 2021

Completamento dello studio (Anticipato)

16 maggio 2021

Date di iscrizione allo studio

Primo inviato

15 novembre 2020

Primo inviato che soddisfa i criteri di controllo qualità

17 novembre 2020

Primo Inserito (Effettivo)

18 novembre 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)