Omega-3 Fatty Acids Supplementation Improves Early-stage Diabetic Nephropathy and Subclinical Atherosclerosis in Pediatric Patients With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetic Nephropathies; Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): oral omega-3 fatty acids supplementation; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment