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

2020年11月17日更新者：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.

調査の概要

状態

わからない

条件

詳細な説明

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.

研究の種類

観察的

入学 (予想される)

1050

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

インド
- Tamil Nadu
  - Chennai、Tamil Nadu、インド、600014
    - Orthomed Hospital
  - Chennai、Tamil Nadu、インド、600024
    - Medway Hospital
  - Chennai、Tamil Nadu、インド、600035
    - Venkateswara Hospital
  - Chennai、Tamil Nadu、インド、600044
    - Dr. Rela Institute & Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～99年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

COVID 19 positive patients with or without diabetes

説明

Inclusion Criteria:

>18 yrs male or female
COVID-19 positive

Exclusion Criteria:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
COVID 19 positive patients without diabetes
COVID 19 positive patients with diabetes

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Severity of COVID 19 among people with and without diabetes 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Number of patients who were in ICU 時間枠：Up to 1 month	Number of patients who were in ICU	Up to 1 month
Number of patients who had tracheal intubation 時間枠：Up to 1 month	Number of patients who had tracheal intubation	Up to 1 month
Number of patients who had respiratory complication 時間枠：Up to 1 month	Number of patients who had respiratory complication	Up to 1 month
Number of death 時間枠：Up to 1 month	Number of death	Up to 1 month
Correlation of BMI with complications, tracheal intubation and mortality 時間枠：Up to 1 month	Correlation of BMI with complications, tracheal intubation and mortality	Up to 1 month
Length of hospital stay 時間枠：Up to 1 month	Length of hospital stay	Up to 1 month

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

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

捜査官

主任研究者：Ambady Ramachandran, M.D,PhD,DSc、President

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (予想される)

2020年11月16日

一次修了 (予想される)

2021年2月16日

研究の完了 (予想される)

2021年5月16日

試験登録日

最初に提出

2020年11月15日

QC基準を満たした最初の提出物

2020年11月17日

最初の投稿 (実際)

2020年11月18日

学習記録の更新

投稿された最後の更新 (実際)