Body Composition in Infants With Klinefelter Syndrome and Effects of Testosterone Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Body Fat Percent Z-score
研究概览
简要总结
This research study in infant males with Klinefelter syndrome (47,XXY) will learn more about body composition (muscle and fat) and male hormones and look at the effect of testosterone shots on body composition. The Investigators know that older boys and men with Klinefelter syndrome often have more fat compared to muscle than adults without Klinefelter syndrome, but we do not know if this difference is present at birth or develops over time. The Investigators will learn if body composition and motor skills are improved with testosterone treatment in infants with Klinefelter syndrome.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 42 Days 至 108 Days（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male infants with 47,XXY karyotype
排除标准
- •Gestational age at birth <36 weeks
- •Birth weight <5%ile or >95% for gestational age
- •History of thrombosis in a first degree relative
- •Exposure to androgen therapy outside of the study protocol.
研究组 & 干预措施
Testosterone treatment
Testosterone cypionate (200 mg/ml) intramuscular injection
干预措施: testosterone cypionate 200mg/ml (Drug)
结局指标
主要结局
Change in Body Fat Percent Z-score
时间窗: Baseline and 3 months
Body fat percentage will be measured using air displacement plethysmography (PEA POD) at the beginning and end of the study period. Age and sex-normed z-scores will be calculated. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Change in the z-score over time, if following a normal growth curve, is 0. Positive change in z-scores indicates a gain in body fat above growth typically expected. Negative change in z-scores indicates a gain in body fat that is less than typically expected.
次要结局
- Serum Luteinizing Hormone (LH)(baseline only)
- Change in Raw Score on the Alberta Infant Motor Scale(3 months)
- Change in Total Motor Standard Score on the Peabody Developmental Motor Scales 2(3 months)
- Serum Follicle Stimulating Hormone (FSH)(baseline only)
- Serum Total Testosterone(baseline only)
- Serum Inhibin B (INHB)(baseline only)
- Serum Anti-Mullerian Hormone (AMH)(baseline only)
- Leptin(baseline only)
- Change in Penile Length(Baseline and 3 months)
- Change in Score on the Movement Assessment of Infants (MAI)(3 months)
- Change in Fat Free Mass(Baseline and 3 months)