| CTRI Number |
CTRI/2023/10/058896 [Registered on: 19/10/2023] Trial Registered Prospectively |
| Last Modified On: |
07/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
The Renal Protective Effect Of SGLT2 Inhibitor Drug In Diabetics Patient Who Are Undergoing Per cutaneous Coronary Interventions. |
|
Scientific Title of Study
|
Impact of SGLT-2 Inhibitors on Renal Function Among the Patients Undergoing Percutaneous Coronary Interventions with Type 2 Diabetes and Coronary Artery Disease: A Cohort 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 |
Shravya PK |
| Designation |
Pharm D |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7349645173 |
| Fax |
|
| Email |
shravyapk18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Roopa Satyanarayan Basutkar |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Science |
| Address |
Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9047155003 |
| Fax |
|
| Email |
roopa.satyanarayan@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Roopa Satyanarayan Basutkar |
| Designation |
Assistant Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Science |
| Address |
Department of Pharmacy Practice,NGSM Institute of Pharmaceutical Sciences
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9047155003 |
| Fax |
|
| Email |
roopa.satyanarayan@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Justice KS Hedge Charitable Hospital and NGSM Institute of Pharmaceutical Sciences, Mangalore
Financial support awaited from Nitte (Deemed to be University) |
|
|
Primary Sponsor
|
| Name |
NGSM Institute of Pharmaceutical Science |
| Address |
NGSM Institute of Pharmaceutical Science, Paneer Campus, Derlakatte, Mangalore |
| Type of Sponsor |
Other [Nitte (Deemed to be University)] |
|
|
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 |
| Shravya PK |
Justice KS Hegde Charitable Hospital |
In Patient Department of Cardiology and Endocrinology
Dakshina Kannada
KARNATAKA |
7349645173
shravyapk18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee NGSMIPS IEC |
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. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SGLT2 inhibitors |
Canagliflozin:oral:initial:100mg once daily; may increase to 300mg once daily after 4-12 weeks
Dapagliflozin: oral:initial:5mg once daily; may increase upto 10mg once daily after 4-12 weeks
Empagliflozin:oral:initial:10mg once daily; may increase to 25mg once daily after 4-12 weeks |
| Comparator Agent |
SGLT2 Inhibitors non Users |
Biguanides-
Metformin:initial:oral:500mg once or twice daily or 850mg once daily
Sulphonylureas- Gliclazide:oral:initial:40-80mg once daily and increase 1-4 weeks
Glimeperide:Oral:initial:1-2mg once daily and increase to 1-2mg every 1-4weeks
Glipizide:Initial:2.5 to 5mg once daily 30 min before food
Glyburide:oral:intial:1.25 to 5mg once daily and increase 2.5 mg/every 1-4 weeks
Meglitinides- Repaglinide:Oral:0.5mg before each meal(upto 4 times a daily
Nateglinide:oral:initial:60-120 mg
Thiazolodinediones-Pioglitzone:oral:initial:15 to 30 mg once daily and increase in 15mg/day incremets every 4-12 weeks
rosiglitazone:oral:Initial:4mg/day as single dose or in divided doses if inadequate after 8-12 weeks dosage increased to 8mg/day as single or divided dose
Alpha-Glucose inhibitors-
Acarbose:Oral:Initial:25 mg 3 times daily increase dose at 4-8 week interval, maximum:50-100mg 3 times daily
Miglitol:oral:Initial:25mg 3 times daily after 4-8 weeks dose titrated to 50mg 3 times daily and continue for 3 months
DPP-4 inhibitors: Alogliptin:25mg once daily
Linagliptin:5 mg once daily
Saxagliptin:2.5-5mg once daily
Sitagliptin:100mg once daily
Vildagliptin: Oral:50mg once or twice daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age - >18 years
Medication duration 3months - 3years
T2DM with indication of PCI
Obstructive coronary artery disease, characterized by a ≥50% narrowing in a major epicardial vessel, and who also have a clinical indication for undergoing PCI.
Willing to provide consent to participate in the study
eGFR range 50-90 ml/min/1.73m2
|
|
| ExclusionCriteria |
| Details |
Auto immune disease
Chronic use of anti-inflammatory medications.
Severe anemia
Dialysis
Cardiogenic shock
Use of nephrotoxic drugs
History of CIN
Use of contrast media less than 7 days
Pregnant
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Serum creatinine values
BUN
eGFR
Requirement of Dialysis
Micro/macroalbuminuria
CI-AKI
Requirement of dialysis
|
At Baseline and 48 hours and 30 to 37 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
At Baseline, biomarkers elevation of creatine kinase MB CKMB less than or equal to 10 times the upper reference limit URL and troponin less than or equal to 70 times the upper reference limit URL within 24 hours after PCI.
ECG Echo
ADRs during the study period.
Occurrence of definite or probable stent thrombosis Until 30 days
Death from CVD cause, MI, Stroke Bleeding Until 30 days.
Complete Blood Count
LVEF
|
At Baseline and 48 hours and 30 to 37 days
|
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
30/10/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
Publication Details
Modification(s)
|
Study was terminated. The publication cannot be taken up |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Type 2 Diabetes Mellitus (T2DM) is a complex and challenging health issue. Twenty-five per cent of patients who undergo elective Percutaneous Coronary Intervention (PCI) have T2DM. In about 1.3 to 33.3% of patients, AKI is primarily attributed to the utilization of contrast medium. And considered as a primary contributing aspect to the development of acute kidney injury (AKI). Contrast agents cause direct toxicity, inflammation, elevated thrombogenic state and decreased renal perfusion among patients undergoing PCI procedures after myocardial infarction with T2DM [9-12]. These patients have a higher risk of developing CI-AKI. It is noted that 40% of the patients on SGLT2-i have a reduction in the progression of kidney disease. The pleiotropic effects of the SGLT2-i on kidney function may potentially reduce CI-AKI among T2DM with CAD conditions who are undergoing PCI procedures [16]. This study aims to evaluate the effect of SGLT2-i on renal function in individuals with coronary artery disease (CAD) and T2DM who are undergoing PCI.
This study is terminated as we were not able to recruit any study participants in the intervention group.
|