Objective: The aim of this study is to determine the effects of omega-3 fatty acid supplementation on inflammatory markers and advanced glycation end products in diabetic nephropathy patients. Study design: Randomized double-blinded controlled clinical trial. Inclusion Criteria: Patients with diabetic nephropathy with FPG ≥ 126 mg/dl, less than 15 years of their disease and aged 35 to 75 years will be included in this study. Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements, patients with chronic kidney disease, liver, lung and chronic or acute inflammatory diseases, heart valve disease, short bowel syndrome and allergies, patients with low immune system ability (autoimmune), pregnant or lactating women will be included in this study. Population and sample size: 60 patients with diabetic nephropathy of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either omega-3 fatty acid (intervention group: n=30) or placebo (control group: n=30). Fasting blood samples will be taken at baseline and after 12-wk intervention. Start and End Date of Intervention: 12 weeks (April 22, 2015-July 24, 2015). Outcomes: Inflammatory markers and advanced glycation end products will be measured at baseline and End-of-trial.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504095623N41
Registration date:2015-04-10, 1394/01/21
Registration timing:prospective
Last update:
Update count:1
Registration date
2015-04-10, 1394/01/21
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-04-16, 1394/01/27
Expected recruitment end date
2015-04-22, 1394/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of omega-3 fatty acid supplementation on inflammatory markers and advanced glycation end products in diabetic nephropaty patients
Public title
Effects omega-3 fatty acid supplementation in the treatment of diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients with diabetic nephropathy with FPG ≥ 126 mg/dl; less than 15 years of their disease; aged 35 to 75 years.
Exclusion Criteria: The use of substitute treatments including hormone or vitamin supplements; patients with chronic kidney disease; liver; lung; chronic or acute inflammatory diseases; heart valve disease; short bowel syndrome and allergies; patients with low immune system ability (autoimmune); pregnant; lactating.
Age
From 35 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
5979
Health conditions studied
1
Description of health condition studied
Diabetic Nephropathy
ICD-10 code
N08.3
ICD-10 code description
Glomerular disorders in diabetes mellitus (E10-E14 with common fourth character .2+)