EUCTR2021-001730-19-ATActive, not recruitingPhase 1
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 sites83 target enrollmentStarted: January 13, 2022Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 83
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
Exclusion Criteria
- •(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
Investigators
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