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临床试验/NCT03767608
NCT03767608已完成不适用

Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus

Instituto Tecnologico y de Estudios Superiores de Monterey1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Correlation of irisin levels and anthropometric parameters in healthy control children

研究概览

简要总结

The objective of this study was to investigate the association of irisin with inflammatory markers as well with metabolic and anthropometric parameters in children and adolescents with type 2 diabetes mellitus compared with healthy controls.

详细描述

Mexican children and adolescents previously diagnosed with type 2 diabetes mellitus according to the American Diabetes Association (ADA) criteria were recruited and compared to healthy controls.

The participants will undergo:

  • vital signs measurement (systolic and diastolic blood pressure, heart rate, respiratory rate)
  • anthropometric variables measurement (BMI, weight, waist circumference, hip circumference, body fat %)
  • laboratory studies: glucose, triglycerides, HDL-c, C reactive protein, irisin

After statistical analyses the investigators will compare the relationship of irisin and the inflammatory profile and the anthropometric parameters of diabetic patients versus lean controls.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • Have been previously diagnosed with T2DM according to the American Diabetes Association (ADA) criteria .
  • Healthy controls were required to have:
  • Normal weight according to the Centers for Disease Control and Prevention (CDC) criteria.
  • No metabolic abnormalities on blood samples
  • No previously diagnosed cardiometabolic diseases
  • Not been using antihypertensive, lipid or glucose lowering medications

排除标准

  • Disapproval by the children's physician due to any at-risk medical condition known by the parents
  • Use of drugs for high blood pressure, hyperglycemia, or dyslipidemia

结局指标

主要结局

Correlation of irisin levels and anthropometric parameters in healthy control children

时间窗: 1 day

Correlation of irisin levels and anthropometric parameters in healthy control children

Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM)

时间窗: 1 day

Correlation of irisin levels and anthropometric parameters in children with T2DM

Correlation of irisin levels and cytokines levels in children with T2DM

时间窗: 1 day

Correlation of irisin levels and cytokines levels in children with T2DM

Comparison between groups

时间窗: 1 day

Compare the correlations of irisin woth anthropometric parameters and INFLAMMATORY MARKERSbetween children diagnosed with T2DM and healthy controls

Correlation of irisin levels and C reactive protein levels in healthy control children

时间窗: 1 day

Correlation of irisin levels and C reactive protein levels in healthy control children

次要结局

未报告次要终点

研究者

发起方
Instituto Tecnologico y de Estudios Superiores de Monterey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Leticia Elizondo-Montemayor

Dean of the Clinical Nutrition and Obesity Research Center. School of Medicine TEC Salud. Tecnológico de Monterrey

Instituto Tecnologico y de Estudios Superiores de Monterey

研究点 (1)

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