Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes
1 other identifier
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 7, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedOctober 10, 2016
October 1, 2016
9 months
October 7, 2016
October 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
effect on on urinary albumin excretion (UAE)
three months
Secondary Outcomes (2)
effect on alpha 1 microglobulin(A1M))
three months
total antioxidant capacity (TAC), malondialdhyde (MDA).
three months
Study Arms (2)
Carnosine oral daily
ACTIVE COMPARATORIntervention group included pediatric patients with diabetic nephropathy receiving oral carnosine daily.
Second arm received placebo oral daily
PLACEBO COMPARATORPlacebo 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.
Interventions
Patients in intervention group received carnosine capsules orally daily
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.
Eligibility Criteria
You may qualify if:
- patients with type 1 diabetes.
- have diabetic nephropathy (≤18 years with at least 5 years disease duration )
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ass.Prof.Nancy Samir Elbarbary
Study Record Dates
First Submitted
October 7, 2016
First Posted
October 10, 2016
Study Start
August 1, 2015
Primary Completion
May 1, 2016
Last Updated
October 10, 2016
Record last verified: 2016-10