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临床试验/NCT02722655
NCT02722655招募中不适用

Characteristics and Evolution of Diabetes Mellitus in Mexican Children: Cohort Study

Hospital Regional de Alta Especialidad del Bajio1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
500
试验地点
1
主要终点
Peripheral diabetic neuropathy

研究概览

简要总结

The aim of this study is the identification of complications in diabetes mellitus pediatric patients and to compare the clinical, anthropometric, and biochemical characteristics between children in the different types of diabetes mellitus.

详细描述

Diabetes mellitus is characterized by hyperglycemia resulting from defects in insulin secretion and/or insulin resistance in target tissues. This study identify the influence of pathogenic factors on the evolution of diabetes mellitus and in the presence of chronic complications.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
1 Month 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with confirmed diagnosis of diabetes mellitus

排除标准

  • 未提供

结局指标

主要结局

Peripheral diabetic neuropathy

时间窗: year 5

A microvascular complication determined by neurological exam in either foot

Microalbuminuria

时间窗: annual

A microvascular complication determined by urine albumin excretion \>= 30 mg/day

Cognitive evaluation

时间窗: year 3

Determined by scores on the Mini-Mental State Examination

Diabetic retinopathy

时间窗: year 3

A microvascular complication determined by ophthalmological evaluation

Nerve damage

时间窗: year 5

A microvascular complication determined by nerve conduction study in either foot

Cardiac function

时间窗: year 5

A cardiovascular risk indicator determined by echocardiogram

Intelligence quotient evaluation

时间窗: year 3

Determined by Intelligence quotient test

次要结局

  • Glycemic control(annual)
  • Pancreatic autoimmunity(onset of diabetes)
  • Body composition(annual)
  • Beta cell function(annual)
  • Alpha cell function(year 5)
  • Hyperlipidemia(annual)
  • Hypothyroidism(annual)
  • Insulin resistance(annual)
  • Hypertension(annual)

研究者

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

Maria Lola Evia-Viscarra

Pediatric Endocrinologist

Hospital Regional de Alta Especialidad del Bajio

研究点 (1)

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