Hormones and Muscle

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001730-19-AT

Enrollment

Registered

2022-01-13

Start date

2022-02-24

Completion date

Unknown

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothyroidism Hypoparathyroidism

Interventions

Trade Name: Euthyrox Product Name: Levothyroxine Pharmaceutical Form: Tablet INN or Proposed INN: LEVOTHYROXINE CAS Number: 51-48-9 Concentration unit: µg microgram(s) Concentration type: range Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria (subclinical hypothyroidism): (i) TSH > 4µU/ml, fT4 within the reverence range. (ii) Age between 18 and 70 years Inclusion criteria: (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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Thyroid: We hypothesize that the measurement of tissue concentrations of phosphodiesters (PDEs) employing 31P MRS represents a sensitive and specific tool to quantify peripheral thyroid hormone action and can be applied in clinical practice to optimize thyroid hormone replacement therapy (metabolic virtual biopsy). Hyper- and Hypoparathyroidism: We propose that the identification of MRS-patterns specific for disorders of calcium metabolism might help to individualize therapeutic decisions in patients with hyper- and hypoparathyroidism. Furthermore, we intend to analyze the time course of MRS-Patterns before and after a single dose of rhPTH 1-84 to determine if PTH per se might have relevant effects on skeletal and heart muscle energy metabolism. Primary outcome parameter: • 31P MRS pattern in skeletal muscle;Secondary Objective: Secondary outcome parameters: 30.04.2021 • Acetylcarnitine levels and ectopic intracellular lipid content in skeletal muscle • Ectopic intracellular lipid content in liver and 31P MRS pattern in the liver (only controls and hypothyroid patients) • Resting energy expenditure • Anthropometric characteristics • Laboratory parameters of thyroid function, i.e. TSH, fT4, fT3, T4, T3, TBG • Laboratory Parameters of Calcium Metabolism, i.e. PTH, Calcium, Kreatinine, Vitamin D, albumin • Laboratory parameters of lipid metabolism, i.e. cholesterol, ldl- and hdl-cholesterol, triglycerides • Laboratory parameters of glucose metabolism, i.e. glucose, insulin, c-peptide, HbA1c • Gender differences • Muscle strength and physical performance • Cardiac function • 31P MRS in Myocardium • Quality of life;Primary end point(s): 31P MRS pattern in skeletal muscle;Timepoint(s) of evaluation of this end point: 4-6 and 8-12 weeks after initiation of Levothyroxine substitution spring 240 min after injection of recombination parathormone	—

Measure

Time frame

Main Objective: Thyroid: We hypothesize that the measurement of tissue concentrations of phosphodiesters (PDEs) employing 31P MRS represents a sensitive and specific tool to quantify peripheral thyroid hormone action and can be applied in clinical practice to optimize thyroid hormone replacement therapy (metabolic virtual biopsy). Hyper- and Hypoparathyroidism: We propose that the identification of MRS-patterns specific for disorders of calcium metabolism might help to individualize therapeutic decisions in patients with hyper- and hypoparathyroidism. Furthermore, we intend to analyze the time course of MRS-Patterns before and after a single dose of rhPTH 1-84 to determine if PTH per se might have relevant effects on skeletal and heart muscle energy metabolism. Primary outcome parameter: • 31P MRS pattern in skeletal muscle;Secondary Objective: Secondary outcome parameters: 30.04.2021 • Acetylcarnitine levels and ectopic intracellular lipid content in skeletal muscle • Ectopic intracellular lipid content in liver and 31P MRS pattern in the liver (only controls and hypothyroid patients) • Resting energy expenditure • Anthropometric characteristics • Laboratory parameters of thyroid function, i.e. TSH, fT4, fT3, T4, T3, TBG • Laboratory Parameters of Calcium Metabolism, i.e. PTH, Calcium, Kreatinine, Vitamin D, albumin • Laboratory parameters of lipid metabolism, i.e. cholesterol, ldl- and hdl-cholesterol, triglycerides • Laboratory parameters of glucose metabolism, i.e. glucose, insulin, c-peptide, HbA1c • Gender differences • Muscle strength and physical performance • Cardiac function • 31P MRS in Myocardium • Quality of life;Primary end point(s): 31P MRS pattern in skeletal muscle;Timepoint(s) of evaluation of this end point: 4-6 and 8-12 weeks after initiation of Levothyroxine substitution spring 240 min after injection of recombination parathormone

—

Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 4-6 and 8-12 weeks after initiation of Levothyroxine substitution spring 240 min after injection of recombination parathormone;Secondary end point(s): Secondary outcome parameters: 30.04.2021 • Acetylcarnitine levels and ectopic intracellular lipid content in skeletal muscle • Ectopic intracellular lipid content in liver and 31P MRS pattern in the liver (only controls and hypothyroid patients) • Resting energy expenditure • Anthropometric characteristics • Laboratory parameters of thyroid function, i.e. TSH, fT4, fT3, T4, T3, TBG • Laboratory Parameters of Calcium Metabolism, i.e. PTH, Calcium, Kreatinine, Vitamin D, albumin • Laboratory parameters of lipid metabolism, i.e. cholesterol, ldl- and hdl-cholesterol, triglycerides • Laboratory parameters of glucose metabolism, i.e. glucose, insulin, c-peptide, HbA1c • Gender differences • Muscle strength and physical performance • Cardiac function • 31P MRS in Myocardium • Quality of life	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 4-6 and 8-12 weeks after initiation of Levothyroxine substitution spring 240 min after injection of recombination parathormone;Secondary end point(s): Secondary outcome parameters: 30.04.2021 • Acetylcarnitine levels and ectopic intracellular lipid content in skeletal muscle • Ectopic intracellular lipid content in liver and 31P MRS pattern in the liver (only controls and hypothyroid patients) • Resting energy expenditure • Anthropometric characteristics • Laboratory parameters of thyroid function, i.e. TSH, fT4, fT3, T4, T3, TBG • Laboratory Parameters of Calcium Metabolism, i.e. PTH, Calcium, Kreatinine, Vitamin D, albumin • Laboratory parameters of lipid metabolism, i.e. cholesterol, ldl- and hdl-cholesterol, triglycerides • Laboratory parameters of glucose metabolism, i.e. glucose, insulin, c-peptide, HbA1c • Gender differences • Muscle strength and physical performance • Cardiac function • 31P MRS in Myocardium • Quality of life

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Countries

Austria

Contacts

Public ContactDepartment of Endocrinology

Medical Univerity of Vienna

endo@meduniwien.ac.at+4314040043111

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 20, 2026