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

17. november 2020 opdateret af: 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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

1050

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 99 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

COVID 19 positive patients with or without diabetes

Beskrivelse

Inclusion Criteria:

  • >18 yrs male or female
  • COVID-19 positive

Exclusion Criteria:

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
COVID 19 positive patients without diabetes
COVID 19 positive patients with diabetes

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Severity of COVID 19 among people with and without diabetes
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients who were in ICU
Tidsramme: Up to 1 month
Number of patients who were in ICU
Up to 1 month
Number of patients who had tracheal intubation
Tidsramme: Up to 1 month
Number of patients who had tracheal intubation
Up to 1 month
Number of patients who had respiratory complication
Tidsramme: Up to 1 month
Number of patients who had respiratory complication
Up to 1 month
Number of death
Tidsramme: Up to 1 month
Number of death
Up to 1 month
Correlation of BMI with complications, tracheal intubation and mortality
Tidsramme: Up to 1 month
Correlation of BMI with complications, tracheal intubation and mortality
Up to 1 month
Length of hospital stay
Tidsramme: Up to 1 month
Length of hospital stay
Up to 1 month

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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

Efterforskere

  • Ledende efterforsker: Ambady Ramachandran, M.D,PhD,DSc, President

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

16. november 2020

Primær færdiggørelse (Forventet)

16. februar 2021

Studieafslutning (Forventet)

16. maj 2021

Datoer for studieregistrering

Først indsendt

15. november 2020

Først indsendt, der opfyldte QC-kriterier

17. november 2020

Først opslået (Faktiske)

18. november 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IDRFARH015

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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