Effect of supplementation in treatment of patients with diabetic nephropathy

The effect of probiotic supplementation on lipid profile, markers of insulin metabolism, biomarkers of inflammation and oxidative stress factors in patients with diabetes nephropathy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017061134458N1

Enrollment

Registered

2017-06-21

Start date

2017-05-15

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Diabetic nephropathy. Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+)

Interventions

Intervention 1: Intervention group: Probiotic supplements containing four strains of Lactobacillus acidophilus (2×109 CFU/g),Lactobacillus fermentum (2×109 CFU/g),Bifidobacterium bifidum (2×109 CFU/

Eligibility

Sex/Gender

All

Age

45 Years to 85 Years

Inclusion criteria

Inclusion criteria: Patients with diabetic nephropathy aged 45 to 85 years

Exclusion criteria

Exclusion criteria: History of active infection within 3 months Intake of probioticand/or synbiotic supplements within 3 months History of hospitaladmission within 3 months Malignancy and/or liver cirrhosis

Design outcomes

Primary

Measure	Time frame
Insulin resistance. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Calculation using HOMA formula.	—

Secondary

Measure	Time frame
Triglyceride. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;HbA1c. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Serum Creatinine. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Blood Urea Nitrogen. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Urine protein. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real-time PCR.;Expressed levels of LDL receptor gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real-time PCR.;Expressed levels of interleukin-1gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method o	—

Measure

Time frame

Triglyceride. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL-cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Hs-CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;HbA1c. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Serum Creatinine. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Blood Urea Nitrogen. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Urine protein. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Expressed levels of PPAR-? gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real-time PCR.;Expressed levels of LDL receptor gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Real-time PCR.;Expressed levels of interleukin-1gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method o

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_r@yahoo.com+98 31 5546 3378

Outcome results

None listed

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