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Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?

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ClinicalTrials.gov Identifier: NCT02567877
Recruitment Status : Recruiting
First Posted : October 5, 2015
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:

Patients taking thyroid hormone replacement after thyroid removal surgery often report feeling differently than they did prior to taking thyroid hormone. The symptoms can include fatigue, worsening mood or subjective "brain fog" where the patient feels like their thinking is just not as sharp as it was previously. Multiple studies have found that patients taking thyroid hormone replacement have a diminished quality of life compared to matched controls. Previous studies have suggested that the type of deiodinase (DIO) polymorphism a patient has, which is responsible for converting the thyroid hormone T4 into the more biologically active T3, may contribute to their overall cognition and sense of well-being. The Investigators aim to determine if the type of deiodinase polymorphism a patient has contributes to the patient's cognition and overall sense of well-being after surgery and thyroid hormone replacement.

Objective: Determine if patients with the deiodinase type 2 CC polymorphism have objective differences in working memory (N-back test is primary endpoint), cognitive function and sense of well-being after thyroidectomy when placed on standard thyroid hormone replacement therapy.

Hypotheses: (1) Patients with the deiodinase type 2 CC polymorphism will have worse working memory (N-back test is primary endpoint), cognitive function and sense of well-being on standard thyroid hormone replacement therapy after thyroidectomy compared with before thyroidectomy.

(2) Patients with the deiodinase type 2 TT or TC polymorphism will have no differences in working memory, cognitive function or sense of well-being on standard thyroid hormone replacement before and after thyroidectomy.


Condition or disease Intervention/treatment
Postsurgical Hypothyroidism Hypothyroidism Procedure: thyroidectomy Drug: levothyroxine in thyroidectomy patients

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Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Levothyroxine Alone Adequate Thyroid Hormone Replacement for All Patients?
Actual Study Start Date : November 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Group/Cohort Intervention/treatment
levothyroxine in thyroidectomy patients
patients undergoing thyroidectomy for nodular thyroid disease
Procedure: thyroidectomy
Patients enrolled in the study will undergo a clinically-indicated thyroidectomy performed as standard of care.
Other Names:
  • near-total thyroidectomy
  • total thyroidectomy

Drug: levothyroxine in thyroidectomy patients
Patients will initiate levothyroxine treatment after surgery consistent with standard of care. The drug dosage will be titrated to TSH goal that matches the pre-surgery TSH (+/- 1 mIU/L)
Other Names:
  • Synthroid
  • Levothyroid
  • Tirosint




Primary Outcome Measures :
  1. Change in working memory (N-back testing) and correlation with deiodinase type 2 polymorphism [ Time Frame: 6-8 months ]
    Change in working memory as assessed by pre- vs post-surgery N-back test scores will be measured and compared between those with the deiodinase type 2 CC polymorphism versus those in the deiodinase type 2 TC and TT polymorphism group


Secondary Outcome Measures :
  1. Change in cognitive function (SART testing) and correlation with deiodinase type 2 polymorphism [ Time Frame: 6-8 months ]
    Changes in cognitive function assessed by SART testing pre- and post-surgery will be compared between those with the deiodinase type 2 CC polymorphism versus those in the deiodinase type 2 TC and TT polymorphism group

  2. Change in Well-being (SF-36, Billewicz, HADS testing) and correlation with deiodinase type 2 polymorphism [ Time Frame: 6-8 months ]
    Changes in well-being will be assessed with the SF-36, Billewicz, and HADS tests pre- and post-surgery will be compared between those with the deiodinase type 2 CC polymorphism versus those in the deiodinase type 2 TC and TT polymorphism group

  3. Correlation of working memory (N-back testing) and correlation with serum thyronamine levels [ Time Frame: 6-8 months ]
    Pre- vs post-surgery N-back test scores will be measured and correlated with pre- and post-surgery serum thyronamine levels

  4. Change in cognitive function (SART testing) and correlation with serum thyronamine levels [ Time Frame: 6-8 months ]
    Cognitive function assessed by SART testing pre- and post-surgery will be determined and correlated with pre- and post-surgery serum thyronamine levels

  5. Change in Well-being (SF-36, Billewicz, HADS testing) and correlation with serum thyronamine levels [ Time Frame: 6-8 months ]
    Well-being will be assessed with the SF-36, Billewicz, and HADS tests pre- and post-surgery and will be correlated with serum thyronamine levels pre- and post-surgery

  6. Change in serum thyronamine levels [ Time Frame: 6-8 months ]
    changes in serum thyronamine levels from pre-surgery to end of study (post-surgery) will be assessed

  7. Change in sex hormone binding globulin (SHBG) [ Time Frame: 6-8 months ]
    changes in serum sex hormone binding globulin levels from pre-surgery to end of study (post-surgery) will be assessed

  8. Change in LDL cholesterol [ Time Frame: 6-8 months ]
    changes in serum LDL levels from pre-surgery to end of study (post-surgery) will be assessed


Biospecimen Retention:   Samples With DNA
blood samples


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing thyroidectomy for nodular thyroid disease or low-risk thyroid cancer
Criteria

Inclusion Criteria:

  • TSH in the ideal reference range (0.4-4.0 milli-international units per liter (mIU/L))
  • Planned thyroidectomy for nodular thyroid disease or low-risk differentiated thyroid cancer (<4cm, no ETE, no expected use of RAI or suppressive levothyroxine therapy)

Exclusion Criteria:

  • History of psychiatric illness (major illness as defined by DSM IV: major depression, schizophrenia, mania, etc). Patients prescribed chronic medications for psychiatric illness, those taking benzodiazepines or anti-seizure medication.
  • Estrogen therapy that is new within the last 6 weeks or if the dose has been changed within the last 6 weeks
  • Positive thyroid antibodies
  • Chronic use (>4 weeks) of concomitant medications that could affect cognition and memory (including sedative hypnotics, selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, Topamax, benzodiazepines, etc.)
  • Pregnancy
  • Steroid therapy
  • Persistent cancer of any type or other major medical illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02567877


Contacts
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Contact: Emma Hulseberg-Dwyer 720-848-5146 Emma.Hulseberg-Dwyer@ucdenver.edu
Contact: Kelsi Deaver, M.D. 720-848-2650 kelsi.deaver@ucdenver.edu

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Emma Hulseberg-Dwyer    720-848-5146    emma.hulseberg-dwyer@ucdenver.edu   
Contact: Kelsi Deaver, MD    720-848-2560    kelsi.deaver@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Charite University, Berlin, Germany
Investigators
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Principal Investigator: Bryan R Haugen, M.D. University of Colorado Denver Anschutz Medical Campus

Publications:
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT02567877    
Other Study ID Numbers: 14-2155
UL1TR001082 ( U.S. NIH Grant/Contract )
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by University of Colorado, Denver:
hypothyroidism
deiodinase polymorphism
cognitive function
thyroidectomy
levothyroxine
Additional relevant MeSH terms:
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Hypothyroidism
Thyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs