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Effect of mirtazapine in treatment of proteinuria and blood sugar control

Evaluating the effect of mirtazapine on proteinuria and blood sugar control in patients with diabetic nephropathy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160412027346N11
Enrollment
96
Registered
2025-05-11
Start date
2025-05-20
Completion date
Unknown
Last updated
2025-08-19

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

Conditions

Diabetic nephropathy. Other specified diabetes mellitus with diabetic nephropathy

Interventions

Intervention 1: Intervention group: 46 patients in the intervention group will receive mirtazapine (manufactured by Tekajeh Pharmaceutical Company) at a dose of 15mg at night before bedtime. During th

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age above 18 years Diabetic nephropathy Proteinuria less than 3 grams per 24 hours Body Mass Index less than 30 Fasting blood sugar between 80 and 130. Hemoglobin (glycated)A1c between 7and 9

Exclusion criteria

Exclusion criteria: Alcohol consumption Antipsychotic and antidepressant drugs concumption Taking drugs with effect on proteinuria except statins, Angiotensin-Converting Enzyme inhibitor(ACEi) and Angiotensin II Receptor Blocker(ARBs) Not receiving ACEIs and ARBs Antiarrhythmic drugs consumption Movement disorders Leukopenia or thrombocytopenia and taking drugs that cause it Pregnancy Lactation

Design outcomes

Primary

MeasureTime frame
Proteinuri. Timepoint: Before the intervention and three months after its initiation. Method of measurement: 24h urine.;Fasting blood sugar level. Timepoint: Before the start of the intervention, one month after the start of the intervention, two months after the start of the intervention, and at the end of the intervention. Method of measurement: Enzymatic glucose oxidase method.;Glycated hemoglobin (A1C). Timepoint: Before the intervention and three months after the intervention. Method of measurement: High-performance liquid chromatography (HPLC) method.

Secondary

MeasureTime frame
Appetite level. Timepoint: Pre-intervention and three months after intervention initiation. Method of measurement: Simplified nutritional appetite questionnaire (SNAQ)questionnaire.;Sleep amount. Timepoint: Pre-intervention and three months after intervention initiation. Method of measurement: Pittsburgh sleep quality index questionnare(PSQI).;Creatinine. Timepoint: Before the start of the intervention, one month after the start of the intervention, two months after the start of the intervention, at the end of the intervention. Method of measurement: Jaffe method.;Blood urea nitrogen. Timepoint: Before the start of the intervention, one month after the start of the intervention, two months after the start of the intervention, at the end of the intervention. Method of measurement: Enzymatic(urease) method.;Thyroid hormone T4. Timepoint: Before the start of the intervention, one month after the start of the intervention, two months after the start of the intervention, at the end of the intervention. Method of measurement: Immunoassay method.;Na. Timepoint: Before the start of the intervention, one month after the start of the intervention, two months after the start of the intervention, at the end of the intervention. Method of measurement: Ion-Selective Electrod method.;Alanine aminotransferase (ALT). Timepoint: Before the start of the intervention, one month after the start of the intervention, two months after the start of the intervention, at the end of the intervention. Method of measurement: Spectrophotometric methods.;Potassium. Timepoint: Before the start of the intervention, one month after the start of the intervention, two months after the start of the intervention, at the end of the intervention. Method of measurement: Ion-Selective electrod method.;High-density lipoprotein. Timepoint: Before the start of the intervention, one month after the start of the intervention, two months after the start of the intervention, at the end of the intervention. Method o

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShadi Ziaie Ardestani

Shahid Beheshti University of Medical Sciences

?Shadi_z73@yahoo.com+98 21 2360 2188

Outcome results

None listed

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