2023-505854-16-00招募中4 期
Klinefelter syndrome – the effect of Testosterone treatment In PubertY A randomized, double-blind placebo-controlled intervention study ‘The TiPY study’
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Change in body composition as evaluated by whole body dual energy x-ray absorptiometry (DEXA) scan and measurement of body fat percentage, ratio between android and gynoid fat percentage and muscle mass.
研究概览
简要总结
The primary study objective is to evaluate the effect of two years testosterone replacement therapy (TRT) during puberty in boys with Klinefelter syndrome on • changes in body composition
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Boys with Klinefelter syndrome (with a 47,XXY karyotype verified by conventional chromosome analysis or ArrayCGH). *Age 10-14 years at inclusion *LH > +2 standard deviations (SD) by ultrasensitive LH assay *Free T<+2SD *Signed consent from parents
排除标准
- •Previous or ongoing T treatment except for TRT because of micropenis during minipuberty *Contraindications to testosterone treatment *Participation in any other clinical trial
结局指标
主要结局
Change in body composition as evaluated by whole body dual energy x-ray absorptiometry (DEXA) scan and measurement of body fat percentage, ratio between android and gynoid fat percentage and muscle mass.
Change in body composition as evaluated by whole body dual energy x-ray absorptiometry (DEXA) scan and measurement of body fat percentage, ratio between android and gynoid fat percentage and muscle mass.
次要结局
- Pubertal development (Tanner stageing), voice frequency and measurement of reproductive hormones in serum.
- Height, weight, sitting-height, head circumference, arm span, measurement of IGF1, IGF1BP3 in serum, and evaluation of bone age (xray)
- serum cholesterol (total, HDL, LDL), triglyceride, free fatty acids, glycerol, adiponectin, leptin, glucose, insulin, HbA1C, IL-6, TNF-α, IL-1RA, hsCRP/CRP
- neuropsychological assessment before and after 2 year treatment
- Bone health evaluated by whole body DEXA and Bone Health Index (BHI), and measurement of bone turnover markers (25-OH-vitamin D, calcium, phosphate, magnesium, PTH, alkaline phosphatase (liver and bone), osteocalcin, PINP (procollagen type I N-terminal propetide), CTX (carboxy terminal telopeptide of collagen type I), RANKL (receptor activator of nuclear factor kappa-B ligand), OPG (osteoprogeterin), Klotho, sclerostin and TRACP 5b (tartrate-resistant acid phosphatase 5b)
- grip-strength
- Electrocardiogram with evaluation of QTc
- Semen quality (if the boy is able and willing to deliver a semen sample)
研究者
Lise Aksglaede
Scientific
Rigshospitalet
研究点 (4)
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