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Investigating the effects of stopping versus continuing metformin use on kidney function in diabetic patients undergoing elective angiography

Investigating the effects of stopping versus continuing metformin use on kidney function in diabetic patients undergoing elective angiography: a randomized clinical trial study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240821062831N1
Enrollment
204
Registered
2024-08-29
Start date
2024-09-22
Completion date
Unknown
Last updated
2024-09-16

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

Conditions

Determining the effects of stopping metformin versus continuing metformin use on kidney function in diabetic patients undergoing elective angiography.

Interventions

Intervention 1: Intervention group: Patients who continue taking metformin during angiography. Intervention 2: Control group: Patients who stop metformin 24 hours before angiography and then restart 7

Sponsors

International Research Center of Gilan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 70 Years

Inclusion criteria

Inclusion criteria: Diabetic people treated with metformin Elective coronary angiography candidate Informed consent to participate in the study People in the age range of 30 to 70 years

Exclusion criteria

Exclusion criteria: Patients who are candidates for emergency angiography Patients who have contraindications for Metformin such as uncompensated heart failure, severe liver disease, severe hypoxemia Acute or chronic metabolic acidosis Failure to fully implement the protocol Glomerular filtration less than 45 ml/min/1.73m2

Design outcomes

Primary

MeasureTime frame
Acute kidney failure following continued use of metformin during hospitalization for elective angiography of diabetic patients in the form of an increase of more than 25% or 0.3 to 0.5 mg/dL in creatinine concentration compared to the baseline value or decrease in urine output to less than It is defined as 0.5 cc per kilogram for 6 hours. Timepoint: Serum creatinine and glomerular filtration will be evaluated before and 72 hours after angiography in both groups. Also the level of serum creatinine will be re-evaluated one month later to evaluate and compare the return of serum creatinine to baseline values. Method of measurement: Serum creatinine is measured by testing the patient's blood sample and glomerular filtration using the Cockcroft-Gault formula.

Secondary

MeasureTime frame
Metformin-associated lactic acidosis defined as arterial pH less than 7.35 and plasma lactate concentration greater than 5 mmol/L. Timepoint: Serum pH and lactate are evaluated on admission and 72 hours after angiography. Method of measurement: Atrial Blood Gas test.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Baharvand

Gilan University of Medical Sciences

Dr.baharcardio@gmail.com+98 13 3366 5874

Outcome results

None listed

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