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IRCT201611155623N93 IRCT 2016-11-22 Vice chancellor for research, Kashan University of Medical Sciences Effect of supplementation in treatment of patients with diabetic nephropathy Clinical trial of the effect of coenzyme Q10 supplementation compared with the placebo on gene expression involved in insulin, lipid and inflammation signaling pathway in patients with diabetic nephropathy 2015-11-06 anticipated 40 Complete https://irct.ir/trial/6123 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To decrease potential confounding effects, all participants will have stratified randomization according to BMI and age. Then, participants in each block will be randomly allocated into two treatment groups to take either supplement or placebo. Randomization will be done by the use of Stat Trek software, Blinding description: Randomization and allocation will be concealed from the researchers and participants until the final analyses are completed. Another person at the Clinic in Kashan who is not involved in the trial and not aware of random sequences, will be assigned the participants to the numbered bottles of capsules. 3 Diabetic nephropathy. Intervention 1: Intervention group: 100 mg coenzyme Q10 (Nature, New York, USA), once a day, for 12 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally. 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 Undecided - It is not yet known if there will be a plan to make this available.
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 81151-87159 +98 31 5546 3378 asemi_r@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Patients with diabetic nephropathy Aged 40 to 80 years 40 years 85 years Both Consumption of any nutritional supplements within 3 months History of active infection within 3 months History of hospital admission within 3 months Malignancy and/or liver cirrhosis Subjects with uncontrolled diabetes Pregnant women N08.3 Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+) Treatment - Drugs Treatment - Drugs Intervention group: 100 mg coenzyme Q10 (Nature, New York, USA), once a day, for 12 weeks orally. Control group: Placebo (Barij Essence, Kashan, Iran), once a day, for 12 weeks orally. Expressed levels of PPAR-γ. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of GLUT-1. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of Lp(a) gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of LL-1 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of LL-8 gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of ox-LDL gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Expressed levels of TGF-B gene. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: PCR. Vice chancellor for research, Kashan University of Medical Sciences Approved 2015-11-05 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)