An interventional study of oral omega-3 fatty acids supplementation and Placebo in Diabetes Mellitus, Type 1, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-08-07.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
The investigators conducted this randomized-controlled trial to assess the effect of oral omega-3 supplementation on glycemic control, lipid profile, albuminuria level, kidney injury molecule-1 (KIM-1) and carotid intima media thickness (CIMT) to participants who were pediatric patients with T1DM and diabetic nephropathy.
Management of diabetic kidney disease (DKD) mainly consists of correction of hyperglycemia, hypertension and dyslipidemia as well as modification of lifestyle. Primary prevention represents prevention from normoalbuminuria to microalbuminuria, while secondary prevention represents prevention from microalbuminuria to macroalbuminuria. Multiple interventional managements with control of blood glucose, blood pressure and lipid, and smoking cessation can significantly improve the prognosis of cardiovascular events and slow down the progression of renal disease.
Omega-3 fatty acids are polyunsaturated fatty acids (PUFAs) derived from fish oil. Numerous studies have evaluated the potential beneficial effects of omega-3 fatty acids on inflammatory, autoimmune, and renal diseases. Due to their anti-inflammatory effects, omega-3 fatty acids have been suggested to protect against kidney damage. Omega-3 fatty acids can reduce proteinuria in patients with chronic glomerular disease and slow immunoglobulin A (IgA) nephropathy. However, the information about the effects of omega-3 fatty acids on kidney function, particularly in diabetic kidney disease still lacks consensus .
No previous study assessed the role of omega-3 fatty acids in diabetes associated complications in particular diabetic nephropathy and subclinical atherosclerosis among pediatric patients with T1DM and there is insufficient evidence to recommend its supplementation for those patients. Therefore, the investigators conducted this study to investigate the role of omega-3 fatty acids as an adjuvant therapy for participants who had diabetic nephropathy in children and adolescents with T1DM and assess its relation glycemic control, microalbuminuria, kidney injury molecule-1, lipid levels and carotid intima media thickness as an index for subclinical atherosclerosis.
534 studies on the registry are indexed under Diabetic Nephropathies; 107 are open to participants now.
This study's enrollment of 70 is below the median of 80 across 377 interventional studies indexed under Diabetic Nephropathies.
Browse Diabetic Nephropathies studies →Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
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Exclusion Criteria:
Intervention group included pediatric patients with diabetic nephropathy receiving oral omega-3 fatty acids supplementation on a daily basis.
Drug: oral omega-3 fatty acids supplementation
Placebo group or control patients received placebo that were similar in appearance to omega 3 fatty acids and the administered dose was as the same schedule as omega 3 fatty acids.
Dietary Supplement: Placebo
oral omega-3 fatty acids supplementation
Patients in placebo group received placebo that were similar in appearance to omega 3 fatty acids and the administered dose was as the same schedule as omega 3 fatty acids.
change in UACR (mg/g creatinine) level
Urinary albumin excretion rate(mg/g creatinine)
Time frame: 6 months
change in KIM-1 level (ng/mL)
KIM-1 level((ng/mL)
Time frame: 6 months
change in HbA1c(%)
HbA1c%
Time frame: 6 months
Plan to share: Undecided — The data will be available on request
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University