Study Results
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View full resultsBasic Information
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COMPLETED
101 participants
OBSERVATIONAL
2019-04-01
2022-03-15
Brief Summary
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A third treatment arm after surgery has been stopped, as deemed currently not feasible to achieve its target.
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Detailed Description
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The study follows patients after radioiodine therapy as well as a control group over half a year, assessing thyroid status, set points, conversion rates, thyroid volume, LT4 administration and dosing, demographic characteristics and quality of life measures. The treatment mode is not part of the study, and determined by criteria and procedures of best standard care. For that reason, a randomised or blinded design is not possible.
Changes and interrelationships between thyroid parameters and QoL measures are analysed within-subjects and between treatment groups.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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surgery (withdrawn, not continuing recruiting)
thyroid patients receiving replacement treatment with levothyroxine (LT4) after thyroidectomy
Levothyroxine Sodium
thyroid hormone replacement
radioiodine
thyroid patients receiving replacement treatment with levothyroxine (LT4) following radioiodine treatment
Levothyroxine Sodium
thyroid hormone replacement
control
thyroid patients followed without surgery or radioiodine treatment
Levothyroxine Sodium
thyroid hormone replacement
Interventions
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Levothyroxine Sodium
thyroid hormone replacement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of a thyroid disease requiring follow-up but no ablative treatment (controls)
* Clinical diagnosis of a thyroid disease requiring surgery stopped recruiting
Exclusion Criteria
* interfering comorbidity
* non-thyroidal illness
* pregnancy
* psychiatric disease
* severe psychological disorder
* lack of consent
18 Years
ALL
No
Sponsors
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Klinikum Lüdenscheid
OTHER
Responsible Party
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Principal Investigators
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Rolf Larisch, Professor
Role: PRINCIPAL_INVESTIGATOR
Director of Department
Rudolf Hoermann, Professor
Role: STUDY_CHAIR
Klinikum Lüdenscheid
Locations
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Department of Nuclear Medicine Klinikum Luedenscheid
Lüdenscheid, North Rhine-Westphalia, Germany
Countries
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References
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Larisch R, Midgley JEM, Dietrich JW, Hoermann R. Symptomatic Relief is Related to Serum Free Triiodothyronine Concentrations during Follow-up in Levothyroxine-Treated Patients with Differentiated Thyroid Cancer. Exp Clin Endocrinol Diabetes. 2018 Sep;126(9):546-552. doi: 10.1055/s-0043-125064. Epub 2018 Feb 2.
Hoermann R, Midgley JEM, Larisch R, Dietrich JW. Recent Advances in Thyroid Hormone Regulation: Toward a New Paradigm for Optimal Diagnosis and Treatment. Front Endocrinol (Lausanne). 2017 Dec 22;8:364. doi: 10.3389/fendo.2017.00364. eCollection 2017.
Hoermann R, Midgley JEM, Larisch R, Dietrich JW. The role of functional thyroid capacity in pituitary thyroid feedback regulation. Eur J Clin Invest. 2018 Oct;48(10):e13003. doi: 10.1111/eci.13003. Epub 2018 Aug 1.
Hoermann R, Midgley JE, Larisch R, Dietrich JW. Homeostatic Control of the Thyroid-Pituitary Axis: Perspectives for Diagnosis and Treatment. Front Endocrinol (Lausanne). 2015 Nov 20;6:177. doi: 10.3389/fendo.2015.00177. eCollection 2015.
Hoermann R, Midgley JEM, Larisch R, Dietrich JWC. Advances in applied homeostatic modelling of the relationship between thyrotropin and free thyroxine. PLoS One. 2017 Nov 20;12(11):e0187232. doi: 10.1371/journal.pone.0187232. eCollection 2017.
Midgley JE, Larisch R, Dietrich JW, Hoermann R. Variation in the biochemical response to l-thyroxine therapy and relationship with peripheral thyroid hormone conversion efficiency. Endocr Connect. 2015 Dec;4(4):196-205. doi: 10.1530/ec-150056.
Hoermann R, Midgley JE, Larisch R, Dietrich JW. Is pituitary TSH an adequate measure of thyroid hormone-controlled homoeostasis during thyroxine treatment? Eur J Endocrinol. 2013 Jan 17;168(2):271-80. doi: 10.1530/EJE-12-0819. Print 2013 Feb.
Winther KH, Cramon P, Watt T, Bjorner JB, Ekholm O, Feldt-Rasmussen U, Groenvold M, Rasmussen AK, Hegedus L, Bonnema SJ. Disease-Specific as Well as Generic Quality of Life Is Widely Impacted in Autoimmune Hypothyroidism and Improves during the First Six Months of Levothyroxine Therapy. PLoS One. 2016 Jun 3;11(6):e0156925. doi: 10.1371/journal.pone.0156925. eCollection 2016.
Dietrich JW, Landgrafe-Mende G, Wiora E, Chatzitomaris A, Klein HH, Midgley JE, Hoermann R. Calculated Parameters of Thyroid Homeostasis: Emerging Tools for Differential Diagnosis and Clinical Research. Front Endocrinol (Lausanne). 2016 Jun 9;7:57. doi: 10.3389/fendo.2016.00057. eCollection 2016.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019-01-30/R3
Identifier Type: OTHER
Identifier Source: secondary_id
2019-01-30/R3
Identifier Type: -
Identifier Source: org_study_id
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