Status:
RECRUITING
Improvement of Laboratory Diagnostics in Hypothyroid Patients Using Levothyroxine
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Hypothyroidism
Eligibility:
All Genders
18-100 years
Brief Summary
Hypothyroidism is a thyroid disorder and one of the most common endocrine disorders. Hypothyroidism can have multiple causes; most patients suffer from primary autoimmune hypothyroidism (Hashimoto's d...
Detailed Description
Hypothyroidism is a thyroid disorder and one of the most common endocrine disorders. Hypothyroid patients have a thyroid hormone deficiency characterized by a shortage of thyroid hormone (TH) in the c...
Eligibility Criteria
Inclusion
- In order to be eligible to participate in this study, a hypothyroid subject must meet all of the following criteria:
- Ability to provide informed consent
- Ability to speak and understand Dutch or English
- Intake of a stable dosage of levothyroxine, meaning the dosage of levothyroxine must not be changed during the appointment at the outpatient clinic
- Diagnosis of one these forms of hypothyroidism
- Patients with primary hypothyroidism: euthyroid based on TSH according to physician
- Patients with hypothyroidism after a total thyroidectomy due to thyroid carcinoma (therefore athyroid): on target TSH according to physician (target TSH depending on stage/severity of carcinoma)
- Patients using L-T4 due to therapy of Graves' disease: euthyroid based on TSH according to physician (TSH cannot be suppressed, namely TSH within reference interval of 0,5-5,0 mU/L)
- Patients with central hypothyroidism: euthyroid based on fT4 according to physician (common is fT4 in the upper limit, reference interval is 12-22 pmol/L)
- In order to be eligible to participate in this study, a healthy control subject must meet all of the following criteria:
- Ability to provide informed consent;
- Ability to speak and understand Dutch or English
- Consider themselves healthy
Exclusion
- A potential hypothyroid subject who meets any of the following criteria will be excluded from participation in this study:
- Not euthyroid according to physician
- Pregnancy
- Patients using L-T4 due to therapy of Graves' disease: if TSH is still suppressed
- Any of the following medication
- Liothyronine (Cytomel)
- Iodide
- Oral contraceptives
- Active treatment of malignancy (other than thyroid carcinoma)
- A potential healthy control subject who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy
- Any of the following medication
- Thyroid medication (a.o. levothyroxine, thiamazol, PTU)
- Lithium
- Amiodarone
- Propranolol
- Iodide
- Glucocorticoids
- Oral contraceptives
- Heparin
- Growth hormone
- Active treatment of malignancy
Key Trial Info
Start Date :
July 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06083636
Start Date
July 26 2022
End Date
June 1 2026
Last Update
October 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Amsterdam UMC
Amsterdam, North Holland, Netherlands, 1105 AZ