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

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02928250

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Oxidative Stress Carnosine Diabetic Nephropathy	Dietary Supplement: Carnosine Dietary Supplement: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Study Start Date :

Aug 1, 2015

Actual Primary Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Carnosine oral daily Intervention group included pediatric patients with diabetic nephropathy receiving oral carnosine daily.	Dietary Supplement: Carnosine Patients in intervention group received carnosine capsules orally daily
Placebo Comparator: 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.	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.

Arm

Intervention/Treatment

Active Comparator: Carnosine oral daily

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

Dietary Supplement: Carnosine

Patients in intervention group received carnosine capsules orally daily

Placebo Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

effect on on urinary albumin excretion (UAE) [three months]

Secondary Outcome Measures

effect on alpha 1 microglobulin(A1M)) [three months]
total antioxidant capacity (TAC), malondialdhyde (MDA). [three months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nancy Samir Elbarbary, Ass.Prof.Nancy Samir Elbarbary, Ain Shams University

ClinicalTrials.gov Identifier:

NCT02928250

Other Study ID Numbers:

Ain Shams University 1361

First Posted:

Oct 10, 2016

Last Update Posted:

Oct 10, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Kidney Diseases

Diabetic Nephropathies

Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Oct 10, 2016