Effect of sitagliptine on proteinuria

Effect of sitagliptine on proteinuria in patients with diabetes type 2

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201028049174N1

Enrollment

Registered

2020-11-07

Start date

2017-07-23

Completion date

Unknown

Last updated

2020-11-30

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 diabetic nephropathy

Interventions

Intervention 1: The intervention group received 50 mg sitagliptin daily ( Dr.Abidi Company, Tehran, Iran) for 12 weeks.Two blood and urine sample were collected from each participant at the baseline a

. Intervention 2: Control group: The control group received daily a placebo (produced by the Pharmaceutical Faculty of the Isfahan University of Medical Sciences in the same size, shape and color).Tw

Eligibility

Sex/Gender

All

Age

No minimum to 80 Years

Inclusion criteria

Inclusion criteria: diabet melitus type 2 age60 BP<140/90 under treatment with ACEI or ARB ( at least six months) sign written informed consent for participating

Exclusion criteria

Exclusion criteria: Peregnancy GFR<60 past history of malignancy severe liver disease, psychosis uncontrolled blood pressure (Blood pressure = 140/90 despite treatment with three antihypertensive drugs) Heart failure Diabetic foot ulcer

Design outcomes

Primary

Measure	Time frame
Urine Albumin-to-Creatinine Ratio. Timepoint: At baseline and 3 months after starting the drug. Method of measurement: Calculation of urine microalbumin (mg/l) divided by the urine creatinine (gr/l).	—

Secondary

Measure	Time frame
Blood pressure. Timepoint: At the beginning of the study, 4, 8,and 12 weeks after the start of the intervention. Method of measurement: Measurement,Blood pressure monitoring.;Body mass index. Timepoint: At the beginning of the study, 4, 8,and 12 weeks after the start of the intervention. Method of measurement: Measurement by weight in kilogram divided by height squared in meters.;HbA1C. Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: High Performance Liquid Chromatograpy(HPLC).;Liver Enzymes (ALT? AST). Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Enzyme kit.;Profile Lipid (TG? LDL? HDL? total cholesterol). Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Enzyme kit.;URIC ACID. Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Enzyme kit.;FBS. Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Enzyme kit.;Glomerular filtration rate (GFR). Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: MDRD formula.;Insulin resistance index(HOMAIR). Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: HOMA-IR = (insulin * glucose ) / 405 for glycemia in mg/dL. In both cases the insulin is in mU/L.	—

Measure

Time frame

Blood pressure. Timepoint: At the beginning of the study, 4, 8,and 12 weeks after the start of the intervention. Method of measurement: Measurement,Blood pressure monitoring.;Body mass index. Timepoint: At the beginning of the study, 4, 8,and 12 weeks after the start of the intervention. Method of measurement: Measurement by weight in kilogram divided by height squared in meters.;HbA1C. Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: High Performance Liquid Chromatograpy(HPLC).;Liver Enzymes (ALT? AST). Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Enzyme kit.;Profile Lipid (TG? LDL? HDL? total cholesterol). Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Enzyme kit.;URIC ACID. Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Enzyme kit.;FBS. Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: Enzyme kit.;Glomerular filtration rate (GFR). Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: MDRD formula.;Insulin resistance index(HOMAIR). Timepoint: At the beginning of the study and 12 weeks after the start of the intervention. Method of measurement: HOMA-IR = (insulin * glucose ) / 405 for glycemia in mg/dL. In both cases the insulin is in mU/L.

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Countries

Iran (Islamic Republic of)

Contacts

Public Contactkachooi ali

Esfahan University of Medical Sciences

Kachuei@med.mui.ac.ir0098313222439

Outcome results

None listed

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