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Is Levothyroxine Alone Adequate Thyroid Hormone Replacement?

NCT02567877 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 12

Last updated 2023-06-08

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

thyroidectomy

Patients enrolled in the study will undergo a clinically-indicated thyroidectomy performed as standard of care.

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)

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Bryan R Haugen, M.D. · University of Colorado Denver Anschutz Medical Campus

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02567877 on ClinicalTrials.gov