Omega-3 Fatty Acids Supplementation Improves Early-stage Diabetic Nephropathy and Subclinical Atherosclerosis in Pediatric Patients With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: oral omega-3 fatty acids supplementation; Dietary Supplement: Placebo

• Registration Number: NCT05980026
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-12-17
• Study Completion: 2023-01-14
• Study First Submitted: 2023-07-28
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-04
• Last Update Submitted: 2023-08-04
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients with T1DM on regular insulin therapy.
• age from 12 to 18 years.
• disease duration at least 5 years.
• having diabetic nephropathy in the form of microalbuminuria (urinary albumin excretion [UAE] 30-299 mg/g creatinine).
• hemoglobin A1c (HbA1c) ≤8.5% (69 mmol/mol).
• persistent microalbuminuria was confirmed by abnormal two or three urine samples over a 3- to 6-months period prior to the study despite angiotensin converting enzyme inhibitors (ACE-Is)

Exclusion Criteria

• patients with any clinical evidence of infection.
• patients with renal impairment due to causes other than diabetes.
• other diabetic complications than nephropathy.
• elevated liver enzymes.
• hyper- or hypo-thyroidism.
• intake of any vitamins or food supplements one month before study.
• participation in a previous investigational drug study within the three months preceding screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral omega-3 fatty acids supplementation	oral omega-3 fatty acids supplementation	Intervention group included pediatric patients with diabetic nephropathy receiving oral omega-3 fatty acids supplementation on a daily basis.
Placebo comparator	Placebo	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.

Primary Outcome Measures

Name	Time	Method
change in UACR (mg/g creatinine) level	6 months	Urinary albumin excretion rate(mg/g creatinine)

Secondary Outcome Measures

Name	Time	Method
change in KIM-1 level (ng/mL)	6 months	KIM-1 level((ng/mL)
change in HbA1c(%)	6 months	HbA1c%

Trial Locations

Locations (1)

Nancy Elbarbary; 🇪🇬 Cairo, Egypt