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临床试验/NCT02928250
NCT02928250已完成不适用

Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes

Ain Shams University0 个研究点目标入组 90 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
主要终点
effect on on urinary albumin excretion (UAE)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • patients with type 1 diabetes.
  • have diabetic nephropathy (≤18 years with at least 5 years disease duration )

排除标准

  • 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.

结局指标

主要结局

effect on on urinary albumin excretion (UAE)

时间窗: three months

次要结局

  • total antioxidant capacity (TAC), malondialdhyde (MDA).(three months)
  • effect on alpha 1 microglobulin(A1M))(three months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Samir Elbarbary

Ass.Prof.Nancy Samir Elbarbary

Ain Shams University

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