The effect of melatonin in patients with diabetic nephropathy

Evaluation of the effect of melatonin supplementation on Insulin metabolism markers, parameters of oxidative stress and gene expression of PPAR-? & ox-LDL in patients with diabetic nephropathy

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20150606022562N5

Enrollment

Registered

2018-12-08

Start date

2018-11-11

Completion date

Unknown

Last updated

2019-01-14

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: Taking 10 mg melatonin at night for 12 weeks. Intervention 2: Control group: Taking placebo for 12 weeks.

Eligibility

Sex/Gender

All

Age

40 Years to 85 Years

Inclusion criteria

Inclusion criteria: GFR 15 to 89 ml per minute Moderate blood pressure (systolic pressure 140-160 and diastolic pressure 80-100 mmHg) No specific cardiovascular disease, cancer, inflammatory diseases, autoimmune and hyper or hypothyroidism Non-presence of urinary tract infection and other factors of proteinuria

Exclusion criteria

Exclusion criteria: Special illness that leads to hospitalization. High blood pressure (systolic pressure upper than 160 and diastolic pressure upper than 100 mmHg) Unwillingness to cooperate Taking fluvoxamine and any antioxidant supplement Working at night shifts Smoking and alcohol consumption Breastfeeding and pregnancy

Design outcomes

Primary

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

Secondary

Measure	Time frame
Triglyceride. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Enzymatic kit.;HDL cholesterol. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Enzymatic kit.;QUICKI. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Calculation using QUICKI formula.;Plasma Malondialdehyde. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.;Plsma protein carbonyl. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.;Plasma total Gluthatione. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.;Plasma total antioxidant capacity. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.;Gene expression of PPAR-?. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Real-Time PCR method.;Gene expression of ox-LDL. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Real-Time PCR method.;C reactive protein. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by turbidimetric method.;Nitric oxide. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.	—

Measure

Time frame

Triglyceride. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Enzymatic kit.;HDL cholesterol. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Enzymatic kit.;QUICKI. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Calculation using QUICKI formula.;Plasma Malondialdehyde. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.;Plsma protein carbonyl. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.;Plasma total Gluthatione. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.;Plasma total antioxidant capacity. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.;Gene expression of PPAR-?. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Real-Time PCR method.;Gene expression of ox-LDL. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: Real-Time PCR method.;C reactive protein. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by turbidimetric method.;Nitric oxide. Timepoint: At the beginning of the study and 12 weeks after intervention. Method of measurement: by Spectrophotometry method.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Fereshte 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