The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism
Status:
Completed
Trial end date:
2018-05-04
Target enrollment:
Participant gender:
Summary
Subclinical hypothyroidism (SCH) is common among the elderly population and has been
associated with neuromuscular impairment. Muscular symptoms such as weakness, myalgia and
cramps are more often reported by SCH patients compared to euthyroid controls. Sarcopenia is
the age-related loss of muscular mass and function and its assessment includes three
dimensions (muscle quantity, muscle strength and physical performance). To date, evidence is
lacking about the effect of thyroid hormone replacement on skeletal muscle impairment in SCH
patients. The aim of the study is therefore to evaluate the impact of levothyroxine therapy
on sarcopenia measures in SCH. This is a nested substudy within two large international
multicenter randomized controlled trial of elderly participants with SCH (TRUST Study,
clinicaltrials.gov ID NCT 01660126; and IEMO Study, Netherland Trial Register ID NTR3851).
Those two trials shared a very similar study design. The cohorts will therefore be analyzed
as a single study population.
Phase:
Phase 4
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Collaborators:
Leiden University Medical Center University of Lausanne Hospitals