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

Type 1 Diabetes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928250
• Other study ID #: Ain Shams University 1361
• Status: Completed
• Phase: N/A
• First received: October 7, 2016
• Last updated: October 7, 2016
• Start date: August 2015

Study information

• Verified date: October 2016
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt : Ain Shams University"Ethical committe"
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carnosine
• Diabetes Mellitus, Type 1
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Oxidative Stress
• Type 1 Diabetes

Intervention

Dietary Supplement:
• Carnosine
Patients in intervention group received carnosine capsules orally daily
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect on on urinary albumin excretion (UAE)		three months	Yes
Secondary	effect on alpha 1 microglobulin(A1M))		three months	No
Secondary	total antioxidant capacity (TAC), malondialdhyde (MDA).		three months	No