Status:
WITHDRAWN
Effects of Thyroid Hormone Enzyme Blocking on Hypothyroidism
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hypothyroidism
Thyroidectomy
Eligibility:
All Genders
18+ years
Brief Summary
Background: \- Hypothyroidism is a condition caused by the loss of function of the thyroid gland. The thyroid gland produces two hormones, T4 and T3. These hormones control the metabolism and functio...
Detailed Description
Thyroid hormone action is an important regulator of the metabolism and the function of many organs. The active form of thyroid hormone is T3, and its blood and tissue levels are the result of the secr...
Eligibility Criteria
Inclusion
- PARTICIPANT INCLUSION CRITERIA:
- Study subjects will be adults older than 18 years who do not have any endogenous thyroid hormone production (i.e. status post total thyroidectomy, or in individuals who have a residual remnant greater than 2 mL, an uptake in the thyroid gland less than 5% while on therapy on 123I uptake scan) and on L-T4 replacement at a minimum dose of 1.6 microg/Kg in a steady state of euthyroidism.
- EXCLUSION CRITERIA:
- \<TAB\>Thyroid uptake \> 5% at 24 hours on (123)I thyroid scan while on replacement therapy (in patients with thyroid gland residue \> 2 mL by ultrasound).
- \<TAB\>Patients who have lipid disorders requiring pharmacologic intervention.
- \<TAB\>Any elevation of AST or ALT above upper limit of normal range.
- \<TAB\>Any reduction of the WBC count below the lower limit of normal range.
- \<TAB\>History of, and/or current diabetes mellitus (fasting glucose \>126 mg/dL or current pharmacologic treatment).
- \<TAB\>Hypertension requiring pharmacologic intervention.
- \<TAB\>Female patients who are on hormonal contraceptives or are breastfeeding.
- \<TAB\>Use of beta blocker medications and amiodarone.
- \<TAB\>Pregnancy (women of child-bearing age must have a negative pregnancy test prior to inclusion).
- \<TAB\>History of vasculitis, viral hepatitis (except A), granulocytopenia.
- \<TAB\>Known allergy or serious adverse event to PTU.
- \<TAB\>Current use of prescription medication or certain non-prescription medications and dietary supplements known to affect thyroid function and/or metabolism, or alter the pharmacokinetics of PTU. Should study volunteers receive other pharmacologic interventions a clinical pharmacist will be consulted to evaluate potential drug-drug interactions.
- \<TAB\>Presence of persistent diarrhea or malabsorption syndromes that would interfere with the patient s ability to adequately absorb medications.
- \<TAB\>Inability to obtain venous access for sample collection, or basal hemoglobin of less than or equal to 12 g/dl.
Exclusion
Key Trial Info
Start Date :
January 4 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 29 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01801033
Start Date
January 4 2013
End Date
November 29 2013
Last Update
October 6 2017
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