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The Renal Protective Effect Of SGLT2 Inhibitor Drug In Diabetics Patient Who Are Undergoing Per cutaneous Coronary Interventions.

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 - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/10/058896
Enrollment
114
Registered
2023-10-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E112- Type 2 diabetes mellitus with kidney complications

Interventions

Intervention1: 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 Control Intervention1: SGLT2 Inhibitors non Users: Biguanides- Metformin:initial:oral:500mg once or twice daily or 850mg once daily Sulphonylureas- G

Sponsors

NGSM Institute of Pharmaceutical Science
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Serum creatinine values BUN eGFR Requirement of Dialysis Micro/macroalbuminuria CI-AKI Requirement of dialysis Timepoint: At Baseline and 48 hours and 30 to 37 days—

Secondary

MeasureTime frame
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 Timepoint: At Baseline and 48 hours and 30 to 37 days—

Countries

India

Contacts

Public ContactRoopa Satyanarayan Basutkar

NGSM Institute of Pharmaceutical Science

roopa.satyanarayan@nitte.edu.in9047155003

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026