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Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes
Plain-language guide to NCT02928250: not phased randomized trial of Carnosine, 90 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02928250
- Phase
- not phased
- Status
- completed
- Start
- 2015-08
- Completion (planned or actual)
- 2016-05
- Participants
- 90 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Type 1 Diabetes; Oxidative Stress; Carnosine; Diabetic Nephropathy
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this not phased trial, researchers set out to test Carnosine.
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 .
Free-radical damage is not the only process to affect the structure of proteins and nucleic acids.
It had two arms (groups): Carnosine oral daily (active comparator) and Second arm received placebo oral daily (placebo comparator).
Intervention group included pediatric patients with diabetic nephropathy receiving oral carnosine daily.
The registry classes the interventions as dietary supplement.
Who Took Part
90 actual participants took part.
It was open to people of any sex aged from 5 years up to 18 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Patients with type 1 diabetes. Have diabetic nephropathy (≤18 years with at least 5 years disease duration ).
The full record lists 2 inclusion and 1 exclusion criteria.
How the Study Was Run
The set-up was randomized, parallel-group and single-blind.
The participants were allocated by chance, so the Carnosine group and the comparison group should start out alike.
The Carnosine group and the comparison group ran side by side rather than switching.
Only one side, usually the participants, was kept unaware of whether Carnosine was given.
Those kept unaware of assignments: participant.
It started in 2015-08 with completion listed for 2016-05.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): effect on on urinary albumin excretion (UAE) (time frame: three months).
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Carnosine in 90 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Carnosine compound page, all human trials.
Our Notes on the Compound
Carnosine: A dipeptide of beta-alanine and histidine found in muscle and brain; studied as a supplement in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.