| 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
|
|
|
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.
|