At the screening visit, age, gender, height, weight, body mass index (BMI), diabetes duration, and blood pressure data were recorded. Urine samples were collected at baseline and after 6 months to assess UACR, MMP-7, PCX, and 8-OHdG using enzyme-linked immunosorbent assay (ELISA) kits. Blood samples were also collected at baseline and after 6 months to assess fasting blood glucose, glycosylated hemoglobin (Hemoglobin A1c), and serum creatinine using standard colorimetric methods.
The estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiological Collaboration (CKD-EPI) equation as it is more accurate at higher levels of renal function and better to be used for clinical assessment of DKD [23 (link)]. The eGFR was calculated at baseline and the end of the study. The primary outcomes were the changes in UACR, serum creatinine, and eGFR after 6 months. Changes in other measured biomarkers were considered secondary outcomes.
Patients had regular visits every month for medication refills and to report if there are any encountered side effects. As far as we know, niclosamide can be taken with or without food and there is no evidence that food affects niclosamide effect. To prevent GIT upset, we advised patients to take niclosamide after a light meal. Every month, all administered medications by each patient were reviewed to exclude any patients taking medications that induce albuminuria or interact with niclosamide.
The estimated glomerular filtration rate (eGFR) was calculated using the Chronic Kidney Disease Epidemiological Collaboration (CKD-EPI) equation as it is more accurate at higher levels of renal function and better to be used for clinical assessment of DKD [23 (link)]. The eGFR was calculated at baseline and the end of the study. The primary outcomes were the changes in UACR, serum creatinine, and eGFR after 6 months. Changes in other measured biomarkers were considered secondary outcomes.
Patients had regular visits every month for medication refills and to report if there are any encountered side effects. As far as we know, niclosamide can be taken with or without food and there is no evidence that food affects niclosamide effect. To prevent GIT upset, we advised patients to take niclosamide after a light meal. Every month, all administered medications by each patient were reviewed to exclude any patients taking medications that induce albuminuria or interact with niclosamide.
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