Back to resultsRole of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes, Oxidative Stress, Carnosine
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carnosine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Carnosine oral daily
Second arm received placebo oral daily
Arm Description
Intervention group included pediatric patients with diabetic nephropathy receiving oral carnosine 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.
Outcomes
Primary Outcome Measures
effect on on urinary albumin excretion (UAE)
Secondary Outcome Measures
effect on alpha 1 microglobulin(A1M))
total antioxidant capacity (TAC), malondialdhyde (MDA).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02928250
Brief Title
Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Oxidative Stress, Carnosine, Diabetic Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carnosine oral daily
Arm Type
Active Comparator
Arm Description
Intervention group included pediatric patients with diabetic nephropathy receiving oral carnosine daily.
Arm Title
Second arm received placebo oral daily
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Carnosine
Intervention Description
Patients in intervention group received carnosine capsules orally daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
effect on on urinary albumin excretion (UAE)
Time Frame
three months
Secondary Outcome Measure Information:
Title
effect on alpha 1 microglobulin(A1M))
Time Frame
three months
Title
total antioxidant capacity (TAC), malondialdhyde (MDA).
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes
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