Phenotype and Genotype Analysis in Congenital Hypothyroidism Due to Thyroid Dysgenesis. The Use of Genetic Analysis in the Early Care of Children With Thyroid Dysgenesis
Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This condition is detected consistently since the late 1970s in France, which has led to early care and a significant improvement in prognosis and intellectual stature of these children. However neurodevelopmental disorders persist in 10-15% of cases. More associated diseases have been reported in approximately 10% of cases. These observations are in most cases poorly understood. The family nature of the CH is now well recognized and a dozen genes involved up to now. However, in the majority of cases (HC not due to a disorder of the organification of iodine), few mutations have been found in the reported number of patients (5-10%), suggesting the involvement of other genes. Some of the genes have been implicated in particular specific syndromic forms but many pathological associations remain unexplained. Also, a more complete genetic elucidation of CH would enable a better understanding of its etiology and thus its risk of familial recurrence (frequently asked questions by parents of children with CH) and secondly the presence of associated pathologies. Main goal: to describe the population with CH (not due to a disorder of the organification of iodine) not only on clinical, biological and radiological (phenotypic analysis) but also on the genetic level to establish a genotype / phenotype correlation.
NCT01916018 — Congenital Hypothyroidism
Status: Completed
http://inclinicaltrials.com/congenital-hypothyroidism/NCT01916018/
Detection of Celiac Disease in Patients With Hypothyroidism
The study evaluates whether hypothyroid patients requiring elevated doses of levothyroxine to maintain a euthyroid state are at increased risk of having celiac disease. It also attempts to determine if there is a threshold level of levothyroxine needed to maintain a euthyroid state in patients with hypothyroidism that should prompt serologic testing for celiac disease.
NCT01862510 — Celiac Disease
Status: Completed
http://inclinicaltrials.com/celiac-disease/NCT01862510/
Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism
Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress. Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.
NCT01848171 — Hypothyroidism
Status: Active, not recruiting
http://inclinicaltrials.com/hypothyroidism/NCT01848171/
Levothyroxine Treatment and Cardiometabolic Outcomes in Adolescents With Down Syndrome
The purpose of this research study is to learn about the effects of treating subclinical hypothyroidism (SCH) with thyroid hormone replacement in children and adolescents with Down syndrome (DS). We hypothesize that treatment of SCH with thyroid hormone replacement will improve cardiometabolic health and quality of life.
NCT01832753 — Down Syndrome
Status: Completed
http://inclinicaltrials.com/down-syndrome/NCT01832753/
The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.
NCT01831869 — Hypothyroidism
Status: Active, not recruiting
http://inclinicaltrials.com/hypothyroidism/NCT01831869/
Effects of Pharmacologic Block of Type-1 Deiodinase on Thyroid Hormone Action and on the Circulating Levels of T3 in Hypothyroid Patients
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 function of many organs. Lack of energy, depression, and constipation are common symptoms of hypothyroidism. T4 is converted into T3, the active form of thyroid hormone, by two enzymes called deiodinases. People with hypothyroidism are treated with a synthetic T4 hormone, which the enzymes convert to T3. This treatment is usually effective, but some people continue to have symptoms even after treatment. Some researchers think that this may be caused by a problem with the enzymes that convert T4 into T3. They want to look at how the enzymes regulate the levels of T4 and T3 in the blood. They will do so by using a drug that blocks the action of one of the two enzymes. Objectives: - To look at how thyroid hormone enzyme blocking affects hypothyroidism treatment medication. Eligibility: - Individuals at least 18 years of age who have hypothyroidism and are on thyroid hormone replacement therapy. Design: - The study consists of one screening visit, 9 days of inpatient hospital admission, and a follow-up visit 2 weeks after discharge. - Participants will be screened with a physical exam and medical history. They will provide blood samples. - Participants will receive balanced-diet meals to take home for the 2 days before they enter the hospital. They will continue this diet while in the hospital. - During the inpatient stay, participants will be monitored with regular blood tests. They will have the following procedures: - Continued thyroid hormone replacement for all 9 days. - Drug to block thyroid enzyme for 7 days. - Metabolism test, with room temperature changes, on days 1, 2, 5, 8, and 9. - Measurements of body fat on days 2, 5, and 8. - Blood glucose tests on days 1 and 9. - Muscle contraction tests on days 1, 2, 4, 5, 8, and 9. - Heart imaging studies on days 2, 5, and 8. - Optional skeletal muscle and fat tissue biopsies on days 1 and 9. - There will be a follow-up visit 2 weeks after leaving the hospital. Participants will have a final physical exam and provide blood samples.
NCT01801033 — Hypothyroidism
Status: Withdrawn
http://inclinicaltrials.com/hypothyroidism/NCT01801033/
Phase II Single Daily-Dose Response Study of a New Liothyronine Sodium (T3) Preparation With Sustained Effects in Hypothyroid Patients
The purpose of this study is to test a new thyroid hormone preparation. The thyroid gland produces two thyroid hormones: mostly T4 and a smaller amount of T3. Thyroid hormone therapy for hypothyroidism or thyroid cancer is generally provided using levothyroxine, which is a synthetic form of T4. T4 is converted into the active hormone T3 in the circulation. Therefore, some researchers believe that T3 levels in T4-treated patients may be slightly lower than in individuals whose own thyroid gland is functioning normally. Symptoms of hypothyroidism have been suggested to occur because of this possible T3 deficiency, although this is controversial. Studies of T3, added to or substituted for T4 in traditional levothyroxine regimens, have generally not shown any benefit of T3. However, it is still possible that no benefit is seen because of the short duration of action or "half-life" of T3. This short-life makes it necessary to dose T3 twice or three times daily. Despite multiple daily doses of T3, T3 levels during its therapy tend to be troubled by peaks and troughs. These peaks can be associated with symptoms of excessive thyroid hormone levels. This study will look at TSH and thyroid hormone levels following a daily dose of a new preparation of T3 that may have longer duration of action than liothyronine. This preparation of T3 is called Thyromax® or BCT303. The investigators believe that steady levels of T3 will be seen after taking Thyromax®. The investigators believe that in patients with hypothyroidism use of Thyromax® in the correct dose will produce normal TSH levels, without producing symptoms of too much thyroid hormone. The goal of future studies is to test whether Thyromax® may be a potential treatment for hypothyroidism, by comparing it with traditional levothyroxine therapy.
NCT01800617 — Hypothyroidism
Status: Completed
http://inclinicaltrials.com/hypothyroidism/NCT01800617/
Single-center, Randomized, Double-Blinded, Comparative Study of the Effectiveness of L-carnitine in Patients'Fatigue Degree Changing With Hypothyroidism Who Take Levothyroxine
L-carnitine and thyroid hormone tended to antagonize reciprocally in human body. Urinary excretion of L-carnitine decreased in hypothyroid patients, and levothyroxine supplementation increased excretion of L-carnitine. The investigators hypothesized that supplying L-carnitine to hypothyroid patients with fatigue symptom could improve the quality of life, and fatigue score in them. Therefore, the investigators planned to compare the efficacy of L-carnitine and placebo in hypothyroid patients who had taken levothyroxine.
NCT01769157 — Hypothyroidism
Status: Completed
http://inclinicaltrials.com/hypothyroidism/NCT01769157/
Desiccated Thyroid Extract Compared to Levothyroxine in the Treatment of Hypothyroidism: A Randomized, Double-blind, Crossover Study.
Our hypothesis is that hypothyroid patients on DTE may have a decrease in symptoms, an improvement of cognitive function, and an increase in sense of well-being/ quality of life equivalently compared with L-T4.
NCT01739972 — Primary Hypothyroidism.
Status: Unknown status
http://inclinicaltrials.com/primary-hypothyroidism/NCT01739972/
Multi-modal Effects of Thyroid Hormone Replacement for Untreated Older Adults With Subclinical Hypothyroidism; a Randomised Placebo-controlled Trial
Subclinical hypothyroidism (SCH) is a common condition among older men and women. Although by definition SCH comprises biochemically mild thyroid hormone deficiency without overt symptoms, it is a possible contributor to multiple problems in older age. Thyroid hormone has effects on numerous physiological systems, including the vascular tree, heart, skeletal muscle and brain. Therefore, thyroxine substitution to overcome thyroid hormone deficiency has the potential to give multisystem benefits to older people with SCH. Small studies have reported reduced atherosclerosis and improved heart function with thyroxine replacement, but no large clinical trials have been performed. Therefore the available evidence is limited, leading to major variations in guidelines and clinical practice, with uncertainty regarding the indications for screening and treatment. The investigators propose a multicentre randomised placebo controlled trial to assess the impact of thyroxine replacement in a minimum of 540 older adults (maximum 750) with persisting SCH (excluding those in whom it is a temporary phenomenon who are unlikely to benefit). The investigators will include older men and women with a wide age range and of varying health status. Outcomes include health related quality of life, muscle strength, executive cognitive function and cardiovascular events, with a minimum of 1 year of follow up. Blood and urine samples will be stored in a biobank, to allow future research on causes of ill health in older people with SCH. The investigators have the support of patient advocacy groups and a consortium with the wide range of expertise and experience required to conduct large scale multicentre clinical trials. The proposal explores the multisystem and quality of life benefits to older people of a tailored approach to management of SCH. This clinical trial should definitively clarify whether thyroxine treatment for SCH provides benefits that are relevant for patients. This trial will provide strong evidence with the potential to improve clinical practice, reduce health care costs and promote healthy ageing of older adults.
NCT01660126 — Subclinical Hypothyroidism
Status: Completed
http://inclinicaltrials.com/subclinical-hypothyroidism/NCT01660126/