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IRCT20150606022562N5 IRCT 2018-12-08 Kashan University of Medical Sciences 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-γ & ox-LDL in patients with diabetic nephropathy 2018-11-11 anticipated 60 Complete https://irct.ir/trial/33269 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed with simple method and random numbers generated by computer software, Blinding description: In this study, participants, researchers, data collectors, evaluators and data analyzers are not aware of which group is placebo or supplemented melatonin groups. 3 diabetic nephropathy. Intervention 1: Intervention group: Taking 10 mg melatonin at night for 12 weeks. Intervention 2: Control group: Taking placebo for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information.
public Dr. Fereshte Bahmani
Medical Faculty, Kashan University of Medical Sciences, Ravand road
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 0021 bahmani@kaums.ac.ir Kashan University of Medical Sciences scientific Dr. Fereshte Bahmani
Medical Faculty, Kashan University of Medical Sciences, Ravand road
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5554 0021 bahmani@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) 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 40 years 85 years Both 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 N08.3* Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2†) Treatment - Drugs Placebo Intervention group: Taking 10 mg melatonin at night for 12 weeks Control group: Taking placebo for 12 weeks 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. 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-γ. 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. Kashan University of Medical Sciences Approved 2018-11-05 Ethics Committee of Kashan university of medical sciences and health services Kashan University of Medical Sciences, Ravand road Kashan Isfehan Iran (Islamic Republic of)