Status:
COMPLETED
The Effect of Thyroid Hormone Therapy on Muscle Mass and Function in Older Adults With Subclinical Hypothyroidism
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
University of Lausanne Hospitals
Leiden University Medical Center
Conditions:
Subclinical Hypothyroidism
Sarcopenia
Eligibility:
All Genders
65+ years
Phase:
PHASE4
Brief 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 rep...
Detailed Description
Background Subclinical hypothyroidism (SCH) is common among the elderly population, with an estimated prevalence of 6-15%. It has been associated with multiple adverse outcomes such as cardiovascular...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 4 2018
Estimated Enrollment :
322 Patients enrolled
Trial Details
Trial ID
NCT04354896
Start Date
May 1 2014
End Date
May 4 2018
Last Update
May 18 2023
Active Locations (5)
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1
Department of Gerontology and Geriatrics, Leiden University Medical Center
Leiden, Netherlands
2
Department of Public Health and Primary Care, Leiden University Medical Center
Leiden, Netherlands
3
Institute for Evidence-Based Medicine in Old Age
Leiden, Netherlands
4
Department of General Internal Medicine
Lausanne, Canton of Vaud, Switzerland, 1011