An interventional study of Carnosine and Placebo in Type 1 Diabetes, Oxidative Stress and Carnosine, sponsored by Ain Shams University. Completed. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2016-10-10.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 90 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Intervention group included pediatric patients with diabetic nephropathy receiving oral carnosine daily.
Dietary Supplement: Carnosine
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.
Dietary Supplement: Placebo
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.
effect on on urinary albumin excretion (UAE)
Time frame: three months
effect on alpha 1 microglobulin(A1M))
Time frame: three months
total antioxidant capacity (TAC), malondialdhyde (MDA).
Time frame: three months
No study locations are listed for this record.
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Ain Shams University