Thyroid Diseases Clinical Trial
Official title:
Peripheral Thyroid Hormone Conversion and Glucose and Energy Metabolism
This study will examine how two thyroid preparations-levothyroxine (T4) and liothyronine
(T3)-affect fat and cholesterol metabolism, blood sugar regulation, and thyrotropin
secretion in patients who have had their thyroid gland removed. Results of the study may
help in the development of better therapies to optimize blood sugar and cholesterol levels
in some patients.
Patients 18 years of age or older who have had most or all of their thyroid gland removed
and are taking long-term thyroid hormone medication may be eligible for this study after
screening.
Thyroid hormone action plays an important role in the regulation of many physiologic
processes, among them glucose and lipid metabolism. Interestingly, the clinical presentation
of thyroid dysfunction is extremely variable, with relatively poor correlation between
circulating hormone levels and clinical features. This finding suggests that the local,
intracellular concentration of the active hormone liothyronine (T3), regulated by peripheral
conversion of the pro-hormone levothyroxine (T4), is an important determinant in the
maintenance of the thyroidal homeostasis.
The aim of the present study is the evaluation of the role of peripheral thyroid hormone
conversion in the regulation of glucose and lipid metabolism by assessing the differential
response to T4 or T3 treatment in subjects devoid of endogenous thyroid hormone production.
T3 administration bypasses peripheral metabolism and therefore will allow us to assess the
role of the peripheral thyroid hormone conversion in the regulation of the hormone action at
the end-organ level.
Fifty hypothyroid subjects will be initially randomized to either of the thyroid hormone
replacements liothyronine (T3) or levothyroxine (T4) treatment period (one arm cross-over
design, with treatment sequence randomized), aimed to maintain serum TSH levels greater than
or equal to 0.5 less than or equal to 1.5 mU/L, indicating full replacement. After a 30-day
period of steady-state replacement the study subjects will be admitted to the Clinical
Center and, after a three-day period of stabilization and an overnight fast, will undergo
the following tests: escalating dose TRH stimulation test, indirect calorimetry, graded
exercise tolerance test, DEXA scan, and echocardiogram.
Patients will also undergo skeletal muscle biopsy and subcutaneous adipose tissue biopsy and
microdialysis, as well as a two-step euglycemic hyperinsulinemic clamp with measurement of
splanchnic gluconeogenesis. Fasting venous blood samples will be collected for the
determination of the parameters of lipid, glucose and energy metabolism.
After discharge, the patients will switch to the other form of thyroid hormone replacement
therapy (second period) . The therapy will be adjusted in order to achieve the same
therapeutic goal for TSH concentrations (greater than or equal to 0.5 less than or equal to
1.5 mU/L), analogous to that achieved during the first phase of the study (TSH less than or
equal to 0.5 mU/L difference between T3 and T4 phases). After reaching a 30-day period of
steady-state replacement, study subjects will be re-admitted to the Clinical Center and the
previously described evaluation procedures will be repeated.
;
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator)
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05975866 -
The Effects of an Anti-inflammatory Diet With or Without Curcumin Supplementation on Anthropometric Measurements, Concentrations of Thyroid Hormones, Anti-TPO, and Systemic Inflammation in Plasma and NFK-B in Peripheral Blood Mononuclear Cells in Patients With Hashimato
|
N/A | |
Terminated |
NCT04589884 -
Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
|
||
Completed |
NCT00569920 -
Nausea and Pain Prophylaxis During Thyroid Surgery
|
N/A | |
Recruiting |
NCT05917067 -
Fluorescence Imaging of the Parathyroid Glands of Children
|
||
Completed |
NCT04704349 -
Latest Imaging SPECT System Evaluation Phase 1
|
N/A | |
Recruiting |
NCT05430139 -
Dried Blood Spot Testing for At Home Health
|
||
Recruiting |
NCT05635266 -
A Single-Site Tissue Repository Providing Annotated Biospecimens for Approved Investigator-directed Biomedical Research Initiatives
|
||
Completed |
NCT01727973 -
Efficacy of Subantimicrobial Dose Doxycycline for Moderate to Severe and Active Graves' Orbitopathy
|
Phase 1/Phase 2 | |
Recruiting |
NCT06112340 -
A Phase 2b Extension Study of Two Doses of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)
|
Phase 2/Phase 3 | |
Recruiting |
NCT05678374 -
Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease
|
||
Not yet recruiting |
NCT04094493 -
Vit D Role in Post Thyroidectomy Hypocalcemia
|
Early Phase 1 | |
Completed |
NCT03157466 -
Respiratory Muscle Function After Thyroid Hormone Replacement Therapy in Nonthyroidal Illness Syndrome
|
||
Completed |
NCT04542278 -
Preoperative Steroids in Autoimmune Thyroid Disease
|
Phase 4 | |
Completed |
NCT04425512 -
Delta Neutrophil Index and Neutrophil Lymphocyte Ratio in Thyroid Malignancy
|
N/A | |
Recruiting |
NCT05510609 -
Three-dimensional Ultrasonography Thyroid Volume Measurement.
|
N/A | |
Recruiting |
NCT05412680 -
Transoral Endoscopic Thyroidectomy by Vestibular Approach (TOETVA)
|
N/A | |
Completed |
NCT06227819 -
BVA-200 vs BVA-100 Validation Study
|
||
Completed |
NCT00150033 -
Health-Related Quality of Life for Thyroid Patients
|
Phase 2 | |
Active, not recruiting |
NCT04351945 -
Endocrine Changes and Their Correction in Heart and Lung Transplant Recipients and Donors
|
||
Enrolling by invitation |
NCT04411290 -
Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
|