| CTRI Number |
CTRI/2021/09/036537 [Registered on: 15/09/2021] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Co-relation of blood sugar levels prior ,during and post hospitalization in Covid -19 patients |
|
Scientific Title of Study
|
A study of patients admitted for Covid-19 infection with respect to their glycemic status before and during hospitalization, and after discharge, and its correlation with their outcomes. |
| Trial Acronym |
DM Covid |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kishor Shelgikar |
| Designation |
Principal Investigator |
| Affiliation |
Ratna Memorial Hospital |
| Address |
Department of Medicine, ICU and NonICU ,968,Senapati Bapat Rd,
Sheti Mahamandal ,Shivaji Co-operative Housing Society,Ramoshivadi ,Wadarvadi Pune
Pune
MAHARASHTRA
411053
India |
| Phone |
912041097777 |
| Fax |
|
| Email |
kishel@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kishor Shelgikar |
| Designation |
Principal Investigator |
| Affiliation |
Ratna Memorial Hospital |
| Address |
Department of medicine ,ICU and Non Icu,968,Senapati Bapat Rd,
Sheti Mahamandal ,Shivaji Co-operative Housing Society,Ramoshivadi ,Wadarvadi Pune
Pune
MAHARASHTRA
411053
India |
| Phone |
912041097777 |
| Fax |
|
| Email |
kishel@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kishor Shelgikar |
| Designation |
Principal Investigator |
| Affiliation |
Ratna Memorial Hospital |
| Address |
Department of Medicine ,ICU and Non Icu ,968,Senapati Bapat Rd,
Sheti Mahamandal ,Shivaji Co-operative Housing Society,Ramoshivadi ,Wadarvadi Pune
Pune
MAHARASHTRA
411053
India |
| Phone |
912041097777 |
| Fax |
|
| Email |
kishel@hotmail.com |
|
|
Source of Monetary or Material Support
|
| MMRS -Maharashtra medical research society,778,Shivajinagar,Opp Kamala Nehru park ,Pune 411004 |
|
|
Primary Sponsor
|
| Name |
MMRS Maharashtra medical research society |
| Address |
778, Shivajinagar, Opposite Kamala Nehru Park, Pune -411004
|
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashwini Bodas |
MMF Ratna Hospital |
Department of Medicine ,ICU and Non ICU,968, Senapati Bapat Rd,
Sheti Mahamandal,
Shivaji Co-operative Housing society,
Ramoshivadi, Wadarvadi
Pune-411053
Pune
MAHARASHTRA |
02041097777
bodasashwini@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adults males and females with Covid-19 positive status admitted at Ratna Memorial Hospital |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complications during hospitalization
Outcomes at discharge
Glycemic status of Covid positive patients at discharge
Type of new-onset diabetes in survivors at 6 months’ follow-up
|
It is a retrospective trial.Subjects will be followed upto 6 months post discharge
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Type of new-onset diabetes in survivors at 6 months’ follow-up
|
Subjects will be followed up for 6 months post discharge for their glycemic status |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/10/2021 |
| 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="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes is associated with increased risk of severe COVID 19. Also new onset diabetes and severe metabolic complications on preexisting diabetes have been observed with patients of Covid 19 suggesting a potential diabetogenic effect of COVID19 beyond the well recognized stress response associated with severe illness .However it is unclear whether the changes in the glucose metabolism will remit or persist after the resolution of infection. This study will improve our understanding about new onset diabetes and Covid 19. |