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临床试验/EUCTR2021-001730-19-AT
EUCTR2021-001730-19-AT进行中(未招募)1 期

Hormones and Muscle– Unravelling the metabolic pathways of endocrine myopathiesA translational magnetic resonance spectroscopy and imaging pilot study - Hormones and Muscle

Medical Univerity of Vienna0 个研究点目标入组 83 人开始时间: 2022年1月13日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
83

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Inclusion criteria (subclinical hypothyroidism):
  • (i) TSH > 4µU/ml, fT4 within the reverence range.
  • (ii) Age between 18 and 70 years
  • (i) Age between 18 and 70 years
  • (ii) Diagnostic criteria fulfilling primary hyperparathyroidism (calcium > 2,5 mmol/l;
  • PTH > upper limit of normal; fractional 24h urinary calcium excretion > 1 %) or hypoparathyroidism (calcium < 2,15 mmol/l; PTH < lower limit of normal)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 83
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • (i) any known disorder of thyroid function, including subclinical and overt hypo- or hyperthyroidism,
  • (ii) positive thyroid autoantibodies (i.e. TRAK, TG-AK, TPO-AK),
  • (iii) current or previous medication for thyroid disorders,
  • (iv) severe metabolic or liver illness (HbA1c > 8%, Triglycerides > 500 mg/dl,
  • Cholesterol > 300 mg/dl, AST & ALT > 3 x upper limit of normal range)
  • (v) pregnancy
  • (vi) breast feeding
  • (vii) general MR-contraindications, including metal devices or other magnetic material
  • hazardous for MR investigation and claustrophobia
  • (viii) statin therapy

研究者

发起方
Medical Univerity of Vienna

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