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

NCT ID: NCT02928250

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31

Brief 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

Type 1 Diabetes; Oxidative Stress; Carnosine; Diabetic Nephropathy

Study Design

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

Study Groups

Carnosine oral daily

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

Group Type: ACTIVE_COMPARATOR

Carnosine

Intervention Type: DIETARY_SUPPLEMENT

Patients in intervention group received carnosine capsules orally daily

Second arm received placebo oral daily

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

Carnosine

Patients in intervention group received carnosine capsules orally daily

Intervention Type: 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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 5 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

Ass.Prof.Nancy Samir Elbarbary

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Ain Shams University 1361

Identifier Type: -

Identifier Source: org_study_id