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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02928250
Other study ID # Ain Shams University 1361
Secondary ID
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. completion date
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


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
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