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

NCT02928250 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2016-10-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Carnosine

Patients in intervention group received carnosine capsules orally daily

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2016-05-31

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02928250 on ClinicalTrials.gov