The effect of selenium on nephropathy complications of diabetic patients

The effects of selenium supplementation on advanced glycation end products, biomarkers of inflammatory and oxidative stress in diabetic nephropathy patients in comparison with placebo: a randomized double-blinded controlled clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015060622562N1

Enrollment

Registered

2015-08-02

Start date

2015-07-11

Completion date

Unknown

Last updated

2019-10-07

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

Conditions

diabetic nephropathy. non-insulin-dependent diabetes mellitus with renal complications

Interventions

Intervention 1: Intervention: received one capsule of 200 µg selenium, daily for three months. Intervention 2: control: received one capsule of placebo daily for three months.

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Inclusion criteria

Inclusion criteria: Diabetic nephropathy with a proteinuria level of >0.3 g/24 hours With or without circulating levels of serum creatinine

Exclusion criteria

Exclusion criteria: The consumption of selenium supplements within 3 months before beginning of the study Patients with uncontrolled diabetes Pregnant women Liver diseases Inflammatory diseases Bacteriuria Haematuria Urinary tract infection History of hospital admission within 3 months

Design outcomes

Primary

Measure	Time frame
Serum insulin. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. mU/ml.;Inflammatory factor hs-CRP. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. ng/ml.;Insulin resistance. Timepoint: Before and three months after intervention. Method of measurement: Calculation using HOMA formula.	—

Measure

Time frame

Serum insulin. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. mU/ml.;Inflammatory factor hs-CRP. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. ng/ml.;Insulin resistance. Timepoint: Before and three months after intervention. Method of measurement: Calculation using HOMA formula.

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Secondary

Measure	Time frame
Matrix metalloproteinases 2 (MMP2). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. ng/ml.;Protein carbonyl. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by cholorimetric method.;Tumor growth factor-beta (TGF-b). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by an enzyme-linking immunosorbent.;Gluthatione peroxidase (GPx). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by an enzyme-linking immunosorbent.;Malondialdehyde (MAD). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by spectrophotometric method.µmol/L.;Advanced glycation end products (AGEs). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by fluorescence method.;Total Gluthatione. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by spectrophotometric method.µmol.;Plasma total antioxidant. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by cholorimetric method.	—

Measure

Time frame

Matrix metalloproteinases 2 (MMP2). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by ELISA kit. ng/ml.;Protein carbonyl. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by cholorimetric method.;Tumor growth factor-beta (TGF-b). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by an enzyme-linking immunosorbent.;Gluthatione peroxidase (GPx). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by an enzyme-linking immunosorbent.;Malondialdehyde (MAD). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by spectrophotometric method.µmol/L.;Advanced glycation end products (AGEs). Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by fluorescence method.;Total Gluthatione. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed.by spectrophotometric method.µmol.;Plasma total antioxidant. Timepoint: Before and three months after intervention. Method of measurement: In serum sample will assessed by cholorimetric method.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fereshteh Bahmani

Kashan University of Medical Sciences

bahmani@kaums.ac.ir+98 31 5554 0021

Outcome results

None listed

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