Clinical Research Directory

Natural History of Thyroid Function Disorders

Participants in this study will be patients diagnosed with or suspected to have a thyroid function disorder. These conditions may include: hypothyroidism, hyperthyroidism, thyroid hormone resistance, Graves' Dermopathy, and thyroid-stimulating hormone (TSH) secreting pituitary adenomas. The main purpose of this study is to further understand the natural history, clinical presentation, and genetics of thyroid function disorders. Many of the tests performed are in the context of standard medical care that is offered to all patients with thyroid function disorders. In addition, blood and tissue samples may be taken for research and genetic studies.

Novel Approaches to the Treatment of Hypothyroidism

Hypothyroidism is a common condition, more frequent in females, associated with excess of cardiovascular risk and poor quality of life not completely abrogated by treatment with levothyroxine. There is an unmet need to define a safe, effective, and feasible regimen to be applied in large trials aimed at assessing levothyroxine/liothyronine combination therapy in patients living with hypothyroidism. To address this knowledge gap we propose a randomized, three-arm, double-blind, controlled, escalating dose parallel pilot study whose results will lay the foundation of large multicenter trial(s) able to demonstrate the effectiveness (or lack thereof) of levothyroxine/liothyronine combination therapy.

Dosing of LT4 in Older Individuals

Our overall goal is to determine the clinical consequences of allowing greater flexibility in LT4 dosing in older individuals who take LT4.

SNUH Immune Checkpoint Inhibitor-induced Hypothyroidism Recovery Trial

The goal of this study is to find out whether hypothyroidism caused by immune checkpoint inhibitors (ICIs) can recover after stopping the ICIs. The study also aims to identify factors that can help predict which patients will be able to stop taking thyroid hormone replacement. The main questions the study will answer are: * What percentage of patients recover normal thyroid function and can stop levothyroxine after stopping ICIs? * What clinical or laboratory factors can predict successful withdrawal of levothyroxine? Participants will: * Be adult cancer patients who developed hypothyroidism during ICI treatment and are currently taking levothyroxine * Have already stopped ICI therapy * Gradually reduce their levothyroxine dose every 3 months if their thyroid function remains normal * Stop levothyroxine if thyroid function remains normal at low doses (≤0.025 mg) * Be monitored with thyroid function tests and clinical symptoms at each visit

Comorbidities Resolution After MGB Surgery and Change in Body Composition

This observational study aims to learn about the correlation between the improving comorbidities associated with obesity after MGB (Mini-Gastric Bypass) surgery and changes in body composition in morbidly obese patients. The main questions it aims to answer are: To study the correlation between the improving comorbidities associated with obesity after MGB(Mini-Gastric Bypass) surgery and changes in body composition. Other objectives are: * Changes in the parameters of the metabolic syndrome after surgery * Changes in the cardiovascular risk biomarkers after metabolic surgery * Emergence in complications arising out of surgery requiring any intervention or causing a prolonged hospital stay, or requiring additional outpatient visits. Type of Study: An observational study in which participants with morbid obesity will undergo mini-gastric bypass surgery as per routine protocol. No separate experimental interventions will be done in the study for the participants.

Optimizing Care for Older Adults Through Thyroid Hormone Deprescribing

The proposed study focuses on testing a novel adapted evidence-based multilevel intervention, Deprescribing Thyroid Hormone In Older Adults (D-THIO), to support thyroid hormone deprescribing (dose de-escalation and/or discontinuation) in older adults with thyroid hormone overtreatment and/or misuse and reduce patient harm. Findings from this study will lay the groundwork for broad implementation of D-THIO and serve as a model for deprescribing inappropriate medications for other endocrine conditions and conditions with biochemical monitoring.

A Study to Assess the Safety and Efficacy of Oral Armour Thyroid Compared to Synthetic T4 for the Treatment of Primary Hypothyroidism in Adult Participants

This study will evaluate the efficacy and safety of Armour Thyroid treatment compared with synthetic T4 in subjects who have primary hypothyroidism and are currently stabilized (i.e., in-range thyroid-stimulating hormone \[TSH\]) on synthetic T4 treatment. This study will also therefore evaluate the efficacy and safety of dose conversion from synthetic T4 therapy to Armour Thyroid therapy.

Walking for Hypothyroidism Trial (WHT)

Women with hypothyroidism often report persistent fatigue, weight gain, autonomic dysregulation, and stress despite stable levothyroxine therapy. This single-center, parallel-group RCT will test whether a structured, supervised 12-week walking program improves basal metabolic rate (BMR) and psychophysiological outcomes compared with usual activity. One hundred twenty women aged 35-55 with stable primary hypothyroidism will be randomized 1:1 to intervention or control.

Improvement of Laboratory Diagnostics in Hypothyroid Patients Using Levothyroxine

Hypothyroidism is a thyroid disorder and one of the most common endocrine disorders. Hypothyroidism can have multiple causes; most patients suffer from primary autoimmune hypothyroidism (Hashimoto's disease), but also central hypothyroidism, hypothyroidism after total thyroidectomy due to thyroid carcinoma, or hypothyroidism due to therapy of Graves' disease occur. Most patients with hypothyroidism are treated with levothyroxine (L-T4) to supplement the lack of thyroxine (T4) produced by their own thyroid. Serum thyroid-stimulating hormone (TSH) and/or free T4 (fT4) are currently measured to assess the efficacy of this therapy and to establish euthyroidism. It is known that fT4 concentrations in patients using L-T4 can be above the upper limit of the reference interval, while their TSH is not (completely) suppressed. This raises the question whether fT4 is an accurate reflection of thyroid hormone status in patients using L-T4. TSH is considered a reliable parameter of thyroid hormone status; however, TSH cannot be used to assess thyroid function in specific hypothyroid patient groups (e.g. central hypothyroidism). Free triiodothyronine (fT3), the active thyroid hormone, has been suggested to be an interesting alternative of fT4 to assess thyroid function. Previously, the methods to measure fT3 were not that robust; however, methods to determine fT3 have been improved, are currently reliable and not susceptible to changes due to L-T4 intake. In addition, the fT3/fT4 ratio is thought to be an interesting candidate in assessing thyroid hormone status as well. The aim of this study is to improve laboratory diagnostics of thyroid hormone status in patients with hypothyroidism receiving L-T4 in whom TSH cannot be used as a reflection of thyroid hormone status. We will primarily investigate the additional already available laboratory tests fT3 and fT3/fT4 ratio. We hypothesize that treated hypothyroid participants who are assumed euthyroid based on TSH (e.g. patients with Hashimoto's hypothyroidism) but have fT4 concentrations above the upper reference limit will more often have a fT3 level or a fT3/fT4 ratio within the reference interval. Concentrations of alternative markers in healthy controls and patients with Hashimoto's hypothyroidism with 'normal' TSH concentrations can, thus, be used to predict thyroid hormone status in patients using L-T4 in whom TSH cannot be used to assess thyroid hormone status.

Gluten Free Diet in Hashimoto's Hypothyroidism

Hashimoto's thyroiditis is an autoimmune condition that reduces functioning of the thyroid gland and can lead to a substantial decline in quality of life for patients, with impacted patients often describing unremitting brain fog, fatigue/malaise and weight gain leading to difficulty functioning in their jobs and homes. It is the most common cause of hypothyroidism in the U.S. and affects up to 10% of the global population. The typical treatment for Hashimoto's is thyroid hormone replacement with medications such as levothyroxine. However, despite adequate treatment as defined by thyroid hormone levels within the reference range, up to 10% of patients will experience persisting symptoms which can dramatically impair quality of life. While various theories have been postulated for the residual symptoms, several studies indicate that they are related to the thyroid autoimmunity, specifically the autoantibodies that are made by the immune system in Hashimoto's thyroiditis in response to the thyroid (ie thyroid peroxidase \[TPO\], thyroglobulin \[Tg\] antibody \[AB\]) and the associated inflammation with the immune response. Removal of thyroid (ie total thyroidectomy) reduces levels of these thyroid antibodies and results in significant improvement in quality-of-life. However, thyroidectomy is an invasive procedure with potential for morbidity such as damage to the recurrent laryngeal (nerve that controls the vocal cords and thus speech), bleeding and infection, so there is interest in other more conservative modalities for lowering the inflammation and autoimmune burden in Hashimoto's thyroiditis. In an effort to identify a less invasive approach for reducing the levels of thyroid antibodies and inflammation, attention has moved to the intersection of Hashimoto's thyroiditis and the gut. Hashimoto's has a strong association with autoimmune disorders impacting the gastrointestinal tract, in particular celiac disease and non-celiac gluten sensitivity (NCGS). NCGS is a condition where there are intestinal and extra-intestinal symptoms associated the consumption of gluten but no presence of anti-tissue transglutaminase antibodies (anti-tTG) which define Celiac Disease. This connection between Hashimoto's thyroiditis and sensitivity to gluten appears to be not only genetic, as those with Celiac Disease/NCGS and Hashimoto's thyroiditis have common HLA haplotypes, but also at the level of the intestine with gut microbiome dysfunction.

Periodization Resistance Training on Quality of Life in Females With Hypothyroidism

This study will be conducted to compare between the effect of nonlinear and linear periodized training on quality of life in females with hypothyroidism.

Patient-centered Dosage of Levothyroxine

Levothyroxine is the most used thyroid hormone replacement when the thyroid gland is failing. Because dosage adjustment normally takes several months, the investigators have developed a decision support tool (DST) that predicts optimal dosage based on repeated blood samples the first 2 weeks after initiation of therapy. In this randomized study the investigators will include patients that start levothyroxine therapy after total thyroidectomy. The use of DST to advice the physician about an early dosage adjustment will be compared with common clinical practice, that is dosage adjustment every 2 months. The effect of DST use will be assessed by studying the possible relationship between fast optimal dose adjustment, patient reported outcome measures, and ability to work.

A Randomized Controlled Trial of Thyroid Hormone Supplementation in Hemodialysis Patients

Hypothyroidism, defined by elevated thyrotropin (TSH) levels, is a common endocrine complication in chronic kidney disease patients, and prior evidence shows that higher TSH levels, even within the normal laboratory range, are strongly associated with impaired quality of life and cardiovascular disease in this population. Levothyroxine is one of the most frequently prescribed medications in chronic kidney disease, yet its efficacy and safety in these patients have not been well-studied. Hence, this study will investigate 1) whether levothyroxine improves patient-centered (e.g., health-related quality of life, physical performance, strength) and 2) cardiovascular (e.g., coronary artery calcification, endothelial function, systolic function) outcomes in dialysis patients, and 3) if thyroid hormone replacement exerts classic metabolic effects (i.e., changes in body fat and resting energy expenditure) in this population.

Interventional Study to Improve Medication Adherence Using Patient Decision Aid

Background: Although hypothyroidism is easily treated with levothyroxine (LT4) replacement, results from several studies indicate that people receiving LT4 replacement often have under- or over-replaced thyroid function. Poor medication adherence and factors interfering with thyroxine absorption and bioavailability may result in such under-replacement. Using the COM-B (Capability, Motivation, and Opportunity - Behavior) model, a health education intervention using patient decision aid (PDA), was developed for primary care physicians to educate individuals about thyroxine replacement. Besides imparting health literacy, PDAs provide greater comfort of the patients to participate in decision making. Intervention with the PDA aims to improve the medication adherence by increasing patients' knowledge about thyroxine replacement. Specific aims: The primary aim is to determine effectiveness of PDA in improving the knowledge, medication adherence and quality of life of the under-replaced hypothyroid adults in a primary care setting. Secondary aims are to explore their understanding and acceptance on the PDA and to assess their perceived usability of this PDA. Methodology: A randomised controlled trial will be conducted at SingHealth Polyclinics (SHP) using mixed-method study design to determine effectiveness of PDA. Patient participants will be randomly allocated in a 1:1 ratio to either the intervention or control group. A total of 236 (118 in each group) patient participants will be enrolled by simple randomization. Eligible patient must be of age ≥21 years years and have LT4 under-replacement with Thyroid stimulating hormone (TSH) \>3.7 mIU/L within the last 6 months. Relevance/significance of the study: Findings from the study may add evidence to the scientific knowledge of using PDA to improve medication adherence and recommend development of similar interventions for other chronic medical conditions.

ThyMoves: Screening and Exercise to Improve Muscle, Enhance Quality of Life, and Reduce Fall Risk in Thyroid Disease

Objectives: This study aims to assess health-related quality of life (QoL) in adults with thyroid hormone disorders and identify modifiable factors to improve QoL in patients with Hashimoto's thyroiditis (HT) and multinodular toxic goiter (MNTG) through an exercise intervention. Primary Outcome: 1\. Assess the impact of a tailored exercise program on health-related QoL in patients with HT and MNTG using the ThyPRO questionnaire. Secondary Outcomes: 1. Evaluate the need for a screening tool to identify thyroid patients with reduced health-related QoL despite being euthyroid. 2. Assess the impact of the exercise intervention on body composition, strength, and balance function in HT and MNTG patients. Methods: The study is a combined cross-sectional survey and randomized controlled trial into the health related QoL in patients diagnosed with thyroid hormone disease. The cross-sectional survey will assess the overall health-related QoL in patients diagnosed with thyroid hormone disease, and help identify eligible participants for the subsequent RCT. The RCT will evaluate the efficacy of a comprehensive screening and exercise intervention in patients ≥ 65 years diagnosed with HT or MNTG, experiencing reduced health-related QoL. Participants: The aim is to recruit 74 patients with HT and 74 patients with MNTG, including 50 participants from each group with reduced health-related QoL (defined in this study as ThyPRO score ≥ 30) and 24 with good health-related QoL (ThyPRO score ≤ 20)

Thyroid Function and Structure in Klinefelter Syndrome

This is a longitudinal retrospective study for the evaluation of thyroid function and structure in patients with Klinefelter syndrome compared to healthy controls and patients affected by chronic lymphocytic thyroiditis.

Clinical Efficacy of Darqeen Capsule for the Management of Hypothyroidism Associated with Female Reproductive Hormonal Imbalance

STUDY OBJECTIVES 1. To assess the safety of Darqeen capsule for the management of Hypothyroidism 2. Evaluate the efficacy of Darqeen capsule for the management of Hypothyroidism 3. To provide an alternative cost-effective treatment for the management of females suffering from hypothyroidism. NULL HYPOTHESIS (HO) The Unani Medicine Darqeen capsule is not effective for the management of Hypothyroidism. ALTERNATE HYPOTHESIS (H1) Unani medicine Darqeen capsule is effective for the management of Hypothyroidism.

Evaluation of Different Diagnostic Therapeutic Strategies in Patients with Thyroid Pathology

Observational single-center prospective and retrospective, nonpharmacological, spontaneous cohort study.

Hypothyroidism After the TAVI Procedure in Elderly Patients

Aortic stenosis is highly prevalent in advancing age. The prognosis of this disease has dramatically changed with the surgical replacement of the aortic valve and the trans catheter aortic valve re-placement (TAVI). The TAVI procedure is also successful in octogenarians and frail patients. However, the evaluation before the TAVI procedure requires a high dosage of iodinated contrast agent with, consequently, an increased risk for thyroid dysfunction. The primary endpoint of this study is to assess, prospectively, the incidence and the predictive factors (underlying thyroid disease, medication, food preservative, topical antiseptics) of hypothyroidism after a TAVI procedure. The secondary endpoint is the influence of the occurrence of hypothyroidism after the TAVI procedure on the geriatric assessment.

Quest to Analyze One Thousand Humans Meditating

This study will be focused on assessing the molecular, physiological, and emotional correlates of an intensive meditation experience in the context of a retreat setting in a large 2000 plus-person cohort comprised of healthy and clinical populations.

Register for Patients With Thyroid Hormone Resistance.

Thyroid hormones (TH) play a pivotal role in the development and function of the mammalian brain. Patients with impaired thyroid hormone transport into the brain tissue or in the case of defective local thyroid hormone receptor (collectively referred to as thyroid hormone resistance) subsequently experience psychomotor disabilities. The "DEEPTYPE" registry has been established with the objective of intensifying the genotyping and, in particular, the neurological phenotyping of patients exhibiting deficiencies in either the thyroid hormone transporter (MCT8) or the thyroid hormone receptor alpha (THRα). The objective of this registry-based study is to enhance the diagnostic yield for MCT8 and THRα deficiencies by employing the serum fT3/fT4 ratio as a more sophisticated screening parameter. Furthermore, the investigators will study the genomic regulation of both genes and attempt to identify further coding and non-coding mutations that result in TH resistance. The patient registry "DEEPTYPE" will document the retrospective and prospective clinical data of identified children in a comprehensive manner. This will enable the identification of three key groups: (i) patients with non-coding mutations, (ii) patients with milder phenotypes presenting only with a subset of symptoms seen in both "classic" conditions, and (iii) patients who are ready for clinical trials.

Efficacy and Safety of Catheter Ablation of Atrial Fibrillation in Patients With Thyroid Hormone Stabilization

Patients with hyperthyroidism or hypothyroidism are often combined with atrial fibrillation, but after the stabilization of thyroid hormone levels after treatment, the patients' atrial fibrillation still persists. Radiofrequency ablation of the atrial fibrillation as one of the treatment options for atrial fibrillation has been widely used in the clinic, and has significant efficacy in maintaining sinus rhythm, improving cardiac function, and improving the prognosis of patients. However, there is a lack of clinical monitoring data on radiofrequency ablation of atrial fibrillation in patients who have combined thyroid dysfunction and have stabilized their thyroid hormone levels after treatment.

The Protection of Thyroid Function in IMRT for Nasopharyngeal Carcinoma

This study aimed to reduce radiation-induced thyroid injury without compromising control of the cervical region by optimizing the delineation of the cervical lymph node drainage area.