Hormones and Muscle

Phase 1

• Conditions: HypothyroidismHypoparathyroidism; Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04]

• Registration Number: EUCTR2021-001730-19-AT
• Lead Sponsor: Medical Univerity of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-13
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified