Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes

Ain Shams University

Status: Completed

Conditions: Diabetic Nephropathy; Type 1 Diabetes; Carnosine; Oxidative Stress

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Carnosine

Study type: Interventional

Funder types: Other

Identifiers

NCT02928250

Ain Shams University 1361

Details and patient eligibility

About

Carnosine, a naturally-occurring dipeptide (β-alanyl-L-histidine) first described in 1900 by Gulewitsch and Amiradzibi, is found predominantly in post-mitotic tissues (e.g. brain and innervated muscle) of vertebrates . Carnosine is claimed to decrease oxygen free-radical mediated damage to cellular macromolecules either by chelating divalent cations or scavenging hydroxy radicals with its imidazole moiety. Free-radical damage is not the only process to affect the structure of proteins and nucleic acids.

To the best of our knowledge, no previous study assessed the role of carnosine in diabetes associated complications in particular diabetic nephropathy and there is insufficient evidence to recommend its supplementation in those patients. Therefore, this study was undertaken to investigate the role of carnosine as an adjuvant therapy for diabetic nephropathy in children and adolescents with type 1 diabetes and assess its relation to microalbuminuria, tubulointerstitial damage marker, glycemic control and oxidative stress.

Enrollment: 90 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with type 1 diabetes.
• have diabetic nephropathy (≤18 years with at least 5 years disease duration )

Exclusion criteria

• any clinical evidence of infection, renal impairment due to causes other than diabetes, elevated liver enzymes, hypertension, neoplasm, hypersensitivity to carnosine, and taking any vitamins or food supplements one month before study or participation in a previous investigational drug study within the 30 days preceding screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups, including a placebo group

Carnosine oral daily

Active Comparator group

Description:

Intervention group included pediatric patients with diabetic nephropathy receiving oral carnosine daily.

Treatment:

Dietary Supplement: Carnosine

Second arm received placebo oral daily

Placebo Comparator group

Description:

Placebo group or control patients received placebo that were similar in appearance to carnosine capsules and the administered dose was as the same schedule as carnosine.

Treatment:

Dietary Supplement: Placebo