NCT07254988终止不适用
Gut Peptides and Bone Remodeling in Children With Neuromuscular Disorders
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- CTX
研究概览
简要总结
Both GIP and GLP-2 reduce bone resorption (measured as CTX) in healthy adult individuals. In this study, we will investigate whether GIP and GLP-2 reduce CTX in children with spinal muscular atrophy, duchenne muscular dystrophy, or cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Diagnosis with Cerebral palsy (CP), Duchenne muscular dystrophy (DMD) or Spinal muscular atrophy (SMA) resulting in the need of a wheelchair
排除标准
- •Use of anti-resorptive medication
- •Confounding illnesses
- •Pregnancy
- •Allergy towards the components given on the test days
- •Hgb<6.5 mmol/L
研究组 & 干预措施
Meal test
Experimental
Oral liquid meal test
干预措施: Meal test (Other)
Glucose dependent insulinotropic polypeptide (GIP) + Glucagon-like-peptide 2 (GLP-2)
Experimental
Subcutaneous co-injection of GIP and GLP-2
干预措施: GIP + GLP-2 (Other)
Placebo
Placebo Comparator
Subcutaneous injection of saline
干预措施: Placebo (Other)
结局指标
主要结局
CTX
时间窗: -10 to 240 minutes
Bone resorption measured as carboxy-terminal telopeptide of type I collagen (CTX)
次要结局
- P1NP(-10 to 240 minutes)
- PTH(-10 to 240 minutes)
- Glucose(-10 to 240 minutes)
- GIP(-10 to 240 minutes)
- GLP-2(-10 to 240 minutes)
- Blood pressure(-10 to 240 minutes)
- Heart rate(-10 to 240 minutes)
研究者
Bolette Hartmann
Principal investigator
University of Copenhagen
研究点 (1)
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