| CTRI Number |
CTRI/2025/03/083103 [Registered on: 21/03/2025] Trial Registered Prospectively |
| Last Modified On: |
05/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Effect of SGLT2 Inhibitors on Kidney Function in People with Diabetes: A Clinical Study |
|
Scientific Title of Study
|
Effect of SGLT2 Inhibitors on Renal Resistive Index in Diabetic Nephropathy Patients : A Quasi-Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chandni Jayakumar |
| Designation |
Post Graduate Student , General Medicine Department , SRM Medical College Hospital and Research Centre |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of General Medicine, SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri, Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
8089758662 |
| Fax |
|
| Email |
cj2788@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandni Jayakumar |
| Designation |
Post Graduate , General Medicine Department , SRM Medical College Hospital and Research Centre |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of General Medicine, SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri, Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
8089758662 |
| Fax |
|
| Email |
cj2788@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chandni Jayakumar |
| Designation |
Post Graduate student , General Medicine Department , SRM Medical College Hospital and Research Centre |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of General Medicine, SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri, Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
8089758662 |
| Fax |
|
| Email |
cj2788@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
SRM Medical College Hospital & Research Centre |
| Address |
SRM Medical College Hospital & Research Centre, SRM Nagar, Potheri, Chengalpattu |
| 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 |
| DrChandni Jayakumar |
SRM MEDICAL COLLEGE HOSPITAL |
Mahatma Gandhi Road , Potheri , SRM Nagar , Kattankulathur , Tamil Nadu 603211
Chennai
TAMIL NADU |
8089758662
cj2788@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE- STUDENTS SRM MEDICAL COLLEGE HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E112||Type 2 diabetes mellitus with kidney complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Renal Resistive Index , Urine Albumin Creatinine Ratio (before 3months) and Renal Resistive Index and Albumin Creatinine Ratio (3months following introduction of T.DAPAGLIFOZIN 10mg once daily) |
We are comparing the values of Renal Resistive Index , Urine Albumin Creatinine Ratio (values obtained 3 months before the introduction of T.DAPAGLIFOZIN 10mg once daily and values of both the parameters which will be obtained 3 months following the introduction of T.DAPAGLIFOZIN 10mg once daily) |
| Intervention |
SGLT2 Inhibitors in Diabetic Nephropathy Patients , that is their effect on various parameters.Here two parameters whose response to SGLT2 Inhibitors (T.DAPAGLIFOZIN 10mg once daily)is being assessed is Renal Resistive Index and urine Albumin Creatinine Ratio |
In my study , I am checking Urine Albumin Creatinine ratio and Renal Resistive Index before introducing SGLT2 Inhibitors(T.DAPAGLIFOZIN 10mg once daily) and checking urine Albumin Creatinine Ratio after 3 months of treatment with SGLT2 Inhibitors(T.DAPAGLIFOZIN 10mg once daily) in the same group of patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria includes patients with Type 2 diabetes mellitus whose Blood pressure is controlled that is within 140/90mmHg , urine albumin creatinine ratio within 300 , estmated glomerular filtration rate more than 60ml/min/1.73 meter square and patient treated with other oral antihyperglycemic agents other than SGLT2 inhibitors |
|
| ExclusionCriteria |
| Details |
Exclusion criteria includes patients with obstructive uropathy , co existent renal pathologies or anomalies , on nephrotoxic drugs , patients with refractory hypertension , patients already on SGLT2 inhibitors and insulin , patients with severe hepatic insufficiency , recurrent urinary tract infection , peripheral vascular disease , fever , infection , menstruating females and excluding females who are within 7 days pre and post menstrual cycle. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| SGLT2 inhibitors ( T.DAPAGLIFOZIN 10mg once daily) contribute to a significant reduction in renal resistive index and urine albumin creatinine ratio , suggesting their potential as a therapeutic option for slowing the progression of diabetic nephropathy |
Primary outcome assessed at 3 months following the start of the drug(T.DAPAGLIFOZIN 10mg once daily) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Renal resistive index can detect
diabetic nephropathy much earlier than urine Albumin Creatinine Ratio.
Here in my study if the Renal Resistive index is high(0.7) for a type 2 Diabetes mellitus patient with urine Albumin Creatinine Ratio within 30mg/g of creatinine which within normal limits , secondary outcome of the study which is to be obtained is that Renal Resistive Index is an effective tool for detecting early diabetic nephropathy & it can be used to follow up diabetic nephropathy. |
secondary outcome assessed at the end of three months |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
31/03/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - PubMED
- For how long will this data be available start date provided 31-03-2025 and end date provided 31-10-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
My study aimed to evaluate the effect of SGLT2 inhibitors on renal resistive index and urine acr. Patients will receive SGLT2 inhibitor therapy for 3 months , after which the measurements were reassessed to determine changes. |