Type 1 DiabetesNCT02928250
Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes
A study testing Carnosine in people with Type 1 Diabetes and Oxidative Stress, run by Ain Shams University.
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 . Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Oxidative Stress, Carnosine
- What is being tested?
- Carnosine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to May 2016
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- patients with type 1 diabetes.
- have diabetic nephropathy (≤18 years with at least 5 years disease duration )
Who cannot join
- 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.
About this study
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.
- Conditions
- Type 1 Diabetes, Oxidative Stress, Carnosine, Diabetic Nephropathy
- Being tested
- Carnosine, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarnosineDietary supplement
Patients in intervention group received carnosine capsules orally daily
PlaceboDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Carnosine oral daily | Active comparator | Intervention group included pediatric patients with diabetic nephropathy receiving oral carnosine daily. Receives: Dietary Supplement: Carnosine |
| Second arm received placebo oral daily | Placebo comparator | 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. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on on urinary albumin excretion (UAE)
Measured: three months
Secondary outcomes (2)
effect on alpha 1 microglobulin(A1M))
Measured: three months
total antioxidant capacity (TAC), malondialdhyde (MDA).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startAug 2015
- Primary completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Samir Elbarbary, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928250
- Sponsor's protocol ID
- Ain Shams University 1361
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2016
- Last updated
- 10 Oct 2016
- Results posted
- No