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additional effect of methylene blue to empagliflozin on diabetic nephropathy

Investigating the additional effect of methylene blue to empagliflozin on nephropathy in patients with type II diabetes

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191228045924N7
Enrollment
50
Registered
2023-11-12
Start date
2023-11-21
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Diabetic nephropathy. Type 2 diabetes mellitus with renal complications

Interventions

Intervention 1: Intervention group: The intervention group includes Diabetic patients in whom microalbuminuria has been confirmed, despite standard treatments (Empagliflozin ) , will be undergone o

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 65 Years

Inclusion criteria

Inclusion criteria: Individuals diagnosed with type 2 diabetes between the ages of 25 and 65 are eligible for inclusion in the study. Patients with a Glomerular Filtration Rate (GFR) greater than 25 and less than 90 Absence of liver insufficiency or active liver disease Absence of active infection and sepsis. Exclusion of professional athletes and individuals who have not engaged in intense physical exercise in the 9 days leading up to the sample collection. Patients not currently undergoing treatment with insulin. Patients with no history of polycystic kidney disease. Absence of acute kidney failure due to causes other than diabetes, such as infection. No history of cardiovascular diseases No history of uncontrolled high blood pressure. Absence of cancer or any other endocrine diseases. Not having Glucose 6-phosphate dehydrogenase (G6PD) deficiency

Exclusion criteria

Exclusion criteria: Patient's non-consent for continued cooperation. Absence of cancer or any other endocrine diseases.

Design outcomes

Primary

MeasureTime frame
Reduction in microalbuminuria. Timepoint: At time point zero (prior to drug administration), three months, and six months after drug administration. Method of measurement: laboratory test.;Enhancement in GFR (Glomerular Filtration Rate). Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: Laboratory test and Calculation of the Glomerular Filtration Rate (GFR).

Secondary

MeasureTime frame
Improvement in creatinine levels. Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: Laboratory test.;Reduction in blood glucose. Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: Laboratory test.;Reduction in blood pressure. Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: Barometer.;Reduction in HbA1C. Timepoint: At time point zero (prior to drug administration), three months, and six months after drug administration. Method of measurement: laboratory test.;Reduction in the incidence of urinary tract infections. Timepoint: At time point zero (prior to drug administration), one month, three months, and six months after drug administration. Method of measurement: laboratory test.;Decrease in serum levels of NO (its metabolites). Timepoint: At time point zero (prior to drug administration), three months, and six months after drug administration. Method of measurement: ELISA.;Reduction in the levels of inflammatory factors((TNF)-a, (IL)-6, (IL)-1ß. Timepoint: At time point zero (prior to drug administration), three months, and six months after drug administration. Method of measurement: ELISA.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDaryoush Hamidi Alamdari

Mashhad University of Medical Sciences

hamidiad@mums.ac.ir+98 51 3882 8574

Outcome results

None listed

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