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临床试验/NCT02821104
NCT02821104已完成不适用

Complement and Cardiovascular Risk in Adolescents

Ohio State University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2016年6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
77
试验地点
1
主要终点
Complement C3 Genotype

研究概览

简要总结

This study evaluates how genetic variations in complement, a part of the immune system, affect cardiovascular risk in adolescents.

详细描述

Cardiometabolic diseases usually do not produce significant mortality and morbidity until adulthood. There is clear evidence, however, that these diseases have their origins in childhood and adolescence. With the rising incidence of obesity associated with poorer eating and less physical activity in children and adolescents it is important that the investigators study these diseases early in their course if the investigators are to prevent future cardiometabolic disease. While obesity clearly increases cardiometabolic risk, not all obese subjects are at increased risk; approximately 25-30% of obese adults and adolescents are metabolically healthy. The complement system is key physiological component in controlling inflammation and recent studies have indicated complement plays an important role in increasing obesity and cardiometabolic risk. Adults with proven cardiometabolic disease or at future risk for cardiometabolic disease have increased levels of the complement components C3, C3a-desArg, and C4 compared to healthy, not at risk, control subjects, independent of obesity. Increased C3 or C3a-desArg levels in adolescents are associated with increased cardiometabolic risk independent of obesity. Two specific single nucleotide polymorphisms (SNPs) in the intron for C3, rs11569562 and rs2250656, both with A>G polymorphisms, are associated with increased serum C3 levels, and increases in a variety of cardiovascular risk factors. No one has investigated how C3 polymorphisms affect risk factors in adolescents. The C4 gene has significant copy number variation and increased copy number is associated with increased C4 levels. The relationship of C4 gene copy number to cardiometabolic risk has not been studied in adults or adolescents. The short-term objectives of this study are to explore differences in cardiometabolic risk factors in overweight and obese adolescents with C3 polymorphisms and also to explore how C4 gene copy number variation affects risk factors. The investigators overall hypothesis is that variations in C3 polymorphisms, C4 gene copy number or both will have significant impact on cardiometabolic health in overweight and obese adolescents. Both traditional and nontraditional cardiometabolic risk markers, including measures of body habitus, blood pressure, lipids, vascular function, insulin secretion and sensitivity, inflammation, and clotting will be investigated in 100 overweight and obese adolescents. The investigators proposed study will help us understand the role of complement and its genetics in the development of cardiometabolic risk and in potentially developing genetic biomarkers for adolescents at increased risk.

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
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adolescents age 12 to 18 years
  • Medication free for 2 weeks except oral contraceptives in females
  • Non Hispanic white

排除标准

  • Chronic medications except for contraceptives in females.
  • History of autoimmune disease either endocrine or connective tissue type
  • History of hematologic or renal disease, malignancy or other chronic disease
  • Hispanic ethnicity,
  • African-American or Asian race

结局指标

主要结局

Complement C3 Genotype

时间窗: Baseline

Genetic C3F genotype allele presence

C4 Copy Number

时间窗: Baseline

C4A or C4B gene copy numbers

次要结局

  • Endothelial Function(8 min)
  • BMI(Baseline)
  • Waist Circumference(Baseline)
  • Body Fat(Baseline)
  • Vascular Stiffness(baseline)
  • Endothelin 1(baseline)
  • Inflammation(baseline)
  • Clotting(baseline)
  • Insulin Sensitivity(baseline)

研究者

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

Robert Hoffman

Professor

Ohio State University

研究点 (1)

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