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CTRI Number  CTRI/2020/12/029712 [Registered on: 10/12/2020] Trial Registered Prospectively
Last Modified On: 08/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Impact of sugars on patients diagnosed with COVID  
Scientific Title of Study   Impact of glycemic variability on the outcome of patients diagnosed with SARS-COV 2 virus  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shravanthi Naidu S Woodayagiri  
Designation  Post graduate 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Department of General Medicine No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu- 600116

Chennai
TAMIL NADU
600116
India 
Phone  9884002755  
Fax    
Email  shravanthi96@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Swathy Moorthy  
Designation  Associate Professor 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Department of General Medicine No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu- 600116

Chennai
TAMIL NADU
600116
India 
Phone  9444016401  
Fax    
Email  swathy.murali@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shravanthi Naidu S Woodayagiri  
Designation  Post graduate 
Affiliation  Sri Ramachandra Institute of Higher Education and Research  
Address  Department of General Medicine No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu- 600116

Chennai
TAMIL NADU
600116
India 
Phone  9884002755  
Fax    
Email  shravanthi96@gmail.com  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research  
 
Primary Sponsor  
Name  Shravanthi Naidu S Woodayagiri  
Address  Post Graduate Department of General Medicine Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 
Type of Sponsor  Other [Principal Investigator] 
 
Details of Secondary Sponsor  
Name  Address 
Swathy Moorthy   Associate Professor Department of General Medicine Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shravanthi Woodayagiri   Sri Ramachandra Institute of Higher Education and Research  Department of General Medicine Sri Ramachandra Institute of Higher Education and Research No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600112
Chennai
TAMIL NADU 
9884002755

shravanthi96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients >18 years who have been diagnosed with SARS COV-2 infection by RTPCR analysis of the nasal swab specimen taken

Type2 diabetes and are on treatment

Patients with impaired glucose tolerance
FBS >100mg/dl but <126mg/dl
PPBS >140mg/dl but <200mg/dl

Stress induced hyperglycemia

Patients with no history of impaired glucose tolerance but have –

Newly diagnosed diabetic patients (as per WHO guidelines)

 
 
ExclusionCriteria 
Details  Patients <18 years of age with SARS COV-2 infection

GDM

Patients with chronic illness such as

Malignancies

Autoimmune disease

Chronic disease requiring steroids

Smokers
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical recovery of the patient   At baseline at 4 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
complications during the hospital stay and immediately after discharge   At baseline and 4 weeks 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/01/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The study is prospective and  will take place in the Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, Porur Chennai between November 2020 and November 2022 after obtaining ethical clearance. It aims to study the impact of glycaemic variability on the outcome of patients diagnosed with sars cov-2 virus. Patients diagnosed with SARS COV-2 infection and fit into our inclusion criteria will be enrolled in the study. After obtaining informed consent, a detailed study proforma will be filled and the details of history (including symptoms and duration), clinical findings and lab parameters will be noted down. Treatment details including the drugs used with dosage and duration, reports of blood investigations and other tests, any complication or adverse event, details of hospitalization and outcome would be documented till discharge. Patients will further be classified according to their HbA1C levels as: Good control (<7%) 2.  Poor control (>7%). Every day CBG will be taken thrice daily. The highest and lowest CBG value, along with the average CBG value will be noted down. Any event requiring shift to the HDU/ICU, ARDS, death, prolonged hospitalization, spO2 <90% will be documented as a major adverse event. Requirement of oxygen support (spO2<94%) with no other complications will be documented as a minor adverse event. The correlation between patients showing a greater glycemic variability and development of complications will be looked for. The results will be tabulated and analyzed statistically with the help of a statistician to identify its statistical significance.


 
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