Cardiometabolic Profiles of Pubertal Boys With Klinefelter Syndrome With or Without One Year of Exogenous Testosterone Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- VO2 peak
研究概览
简要总结
This study plans to learn more about how to measure the way the the body's energy system works in boys with Klinefelter syndrome, including the heart, lungs, muscles, and liver. This is important to know so that investigators understand how hormones and an extra X chromosome relate to diseases such as diabetes, extra weight gain, heart disease and liver diseases.
详细描述
Klinefelter syndrome (KS) is the most common chromosomal abnormality in males and is associated with primary gonadal failure in adolescence and a high morbidity and mortality from cardiovascular-related diseases (CVD) in adulthood. Recent studies in children and adolescent boys with KS have found a high prevalence of CVD risk markers, however the underlying mechanisms have not been explored. Our central hypothesis is that pubertal boys with KS have relative testosterone deficiency resulting in abnormal energy metabolism that predisposes them to later CVD, and that exogenous testosterone will modify these abnormalities.
In this study, investigators will measure markers of cardiometabolic risk in pubertal boys with KS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 47,XXY karyotype (non-mosaic)
- •Age 12-17 years
- •Tanner stage 3-5 pubic hair
- •T naïve group only: No exogenous androgen exposure within the past 5 years
- •T exposed group only: currently on topical testosterone, with duration of treatment between 1-2 years.
排除标准
- •Cognitive, psychiatric, or physical impairment resulting in inability to tolerate the study procedures
- •MRI incompatible metal
- •Diagnosis of type 1 or type 2 diabetes
- •Hypertension greater than 140/90 mm/Hg at rest (would make exercise studies unsafe)
- •Weight > 300 lbs (limit for DEXA)
- •Testosterone treatment for <1 year or >2 years
结局指标
主要结局
VO2 peak
时间窗: baseline
The primary outcome will be peak oxygen consumption (VO2 peak) during exercise on a bicycle ergometer
次要结局
- Body composition(baseline)
- Muscle mitochondrial metabolism(baseline)
- Insulin sensitivity(baseline)
- Liver fat(baseline)