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

17 november 2020 uppdaterad av: 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.

Studieöversikt

Status

Okänd

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Förväntat)

1050

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Indien
    • Tamil Nadu
      • Chennai, Tamil Nadu, Indien, 600014
        • Orthomed Hospital
        • Kontakt:
          • Subair Khan, M.S
      • Chennai, Tamil Nadu, Indien, 600024
        • Medway Hospital
        • Kontakt:
          • Palaniappan T, M.D
      • Chennai, Tamil Nadu, Indien, 600035
        • Venkateswara Hospital
        • Kontakt:
          • Su Thillai Vallal, M.D
      • Chennai, Tamil Nadu, Indien, 600044
        • Dr. Rela Institute & Medical Center
        • Kontakt:
          • Sruti Chandrasekaran, M.D.,D.M

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Icke-sannolikhetsprov

Studera befolkning

COVID 19 positive patients with or without diabetes

Beskrivning

Inclusion Criteria:

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

Exclusion Criteria:

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
COVID 19 positive patients without diabetes
COVID 19 positive patients with diabetes

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Severity of COVID 19 among people with and without diabetes
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

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

Utredare

  • Huvudutredare: Ambady Ramachandran, M.D,PhD,DSc, President

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Förväntat)

16 november 2020

Primärt slutförande (Förväntat)

16 februari 2021

Avslutad studie (Förväntat)

16 maj 2021

Studieregistreringsdatum

Först inskickad

15 november 2020

Först inskickad som uppfyllde QC-kriterierna

17 november 2020

Första postat (Faktisk)

18 november 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 november 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 november 2020

Senast verifierad

1 november 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • IDRFARH015

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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