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

NCT ID: NCT05980026

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2023-01-14

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

oral omega-3 fatty acids supplementation

Intervention Type: DRUG

oral omega-3 fatty acids supplementation

Placebo comparator

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

oral omega-3 fatty acids supplementation

oral omega-3 fatty acids supplementation

Intervention Type: DRUG

Placebo

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Nancy Samir Elbarbary

Prof. of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Nancy Elbarbary

Cairo, , Egypt

Countries

Egypt

References

Elbarbary NS, Ismail EAR, Mohamed SA. Omega-3 fatty acids supplementation improves early-stage diabetic nephropathy and subclinical atherosclerosis in pediatric patients with type 1 diabetes: A randomized controlled trial. Clin Nutr. 2023 Dec;42(12):2372-2380. doi: 10.1016/j.clnu.2023.10.007. Epub 2023 Oct 13.

Reference Type: DERIVED

PMID: 37862823 (View on PubMed)

Other Identifiers

Ain shams Pediatrics 202021

Identifier Type: -

Identifier Source: org_study_id