Investigating the effect of telmisartan in comparison with valsartan and losartan in the amount of albuminuria in patients with diabetic nephropathy

Determine the effectiveness of telmisartan in reducing albuminuria in patients with type 2 diabetes with recent microalbuminuria compared to valsartan and losartan.

A controlled, parallel-group, randomized, phase 3 clinical trial on 152 patients. The rand function of Excel software was used for randomization.

The samples will be selected from patients referred to Valiasr Hospital in Zanjan in 1404. They will be randomly assigned to four treatment groups with one of the drugs losartan 25, valsartan 40, and telmisartan 40 daily for 3 months, while the control group will not receive any medication. At the beginning and at the end of the 3-month treatment period, systolic and diastolic blood pressure, as well as serum Cr, urinary albumin, urinary protein to serum creatinine ratio in the morning, and urinary albumin to serum creatinine ratio in the morning will be measured and calculated.

Inclusion criteria: Age 30 to 70 years, history of type 2 diabetes for more than 5 to 10 years, hba1c> 10%, gfr> 60, >30first-morning spot UAC<300 Exclusion criteria: Pregnant women, kidney disease not related to diabetes, history of heart failure, stroke, chronic liver disease, prostate diseases in men, type 1 diabetes,

Intervention group 1 includes patients with diabetic nephropathy who receive telmisartan intervention. Intervention group 2 includes patients with diabetic nephropathy who receive losartan intervention. Intervention group 3 includes patients with diabetic nephropathy who receive valsartan intervention. Group 4 includes patients with diabetic nephropathy who receive no medication.

Albuminuria, blood pressure, serum creatinine levels

Participants will be randomly allocated to one of four study groups (telmisartan, losartan, valsartan, or control) using block randomization with a 1:1:1:1 allocation ratio. The random allocation sequence will be generated using Random Allocation Software with a block size of four. The unit of randomization is the individual eligible participant. To ensure allocation concealment, the randomization sequence will be prepared by a person who is not involved in participant recruitment or outcome assessment. The allocation sequence will be kept in sequentially numbered, opaque, sealed envelopes (SNOSE). After confirming eligibility and obtaining written informed consent, the next envelope in sequence will be opened to determine the participant's treatment allocation. The person generating the randomization sequence will have no role in participant enrollment or outcome assessment.

All data can be shared after the study is completed and individuals are de-identified.

Access period starts 6 months after results are published.

Researchers working in academic and scientific institutions

The documents will be usable with reference to the source and the study direction.

Email address mohammad68.n121@gmail.com Mohammadli shahmoradi

After sending the email to the researcher, she will immediately receive the documentation.