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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05980026
• Other study ID #: Ain shams Pediatrics 202021
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: January 14, 2023

Study information

• Verified date: August 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 14, 2023
• Est. primary completion date: December 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetic Nephropathies

Intervention

Drug:
• oral omega-3 fatty acids supplementation
oral omega-3 fatty acids supplementation

Dietary Supplement:
• 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.

Locations

Country	Name	City	State
Egypt	Nancy Elbarbary	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in UACR (mg/g creatinine) level	Urinary albumin excretion rate(mg/g creatinine)	6 months
Secondary	change in KIM-1 level (ng/mL)	KIM-1 level((ng/mL)	6 months
Secondary	change in HbA1c(%)	HbA1c%	6 months