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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborators: Leiden University Medical Center; University of Lausanne Hospitals

Criteria

Inclusion Criteria (TRUST):

• Community-dwelling elderly patients aged ≥65 years with subclinical hypothyroidism (SCH).

[SCH is defined as elevated TSH levels (4.6 to 19.9 mU/L) and free thyroxine (fT4) in reference range measured on a minimum of two occasions at least 3 months apart.]

Inclusion Criteria (IEMO)

• Community-dwelling elderly patients aged ≥80 years with SCH, as above defined

Exclusion Criteria (TRUST and IEMO):

• Currently on Levothyroxine or antithyroid drugs, amiodarone or lithium.

• Recent thyroid surgery or radio-iodine (within 12 months).

• Grade IV NYHA heart failure.

• Prior clinical diagnosis of dementia.

• Recent hospitalisation for major illness or elective surgery (within 4 weeks).

• Recent acute coronary syndrome, including myocardial infarction or unstable angina (within 4 weeks).

• Terminal illness.

• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption.

• Individuals participating in ongoing RCTs of therapeutic interventions (including CTIMPs)

• Individuals planning to move out of the region in which the trial is being conducted within the next 2 years (proposed minimum follow-up period).