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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR EUTHYROX

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Clinical Trials for Euthyrox

Trial ID Title Status Sponsor Phase Summary
NCT01379170 Thyroid Study Type 2 Diabetes Mellitus (T2DM) Unknown status Maastricht University Medical Center Phase 4 Background of the study: Thyroid hormones, thyroxine (T4) and triiodothyronine (T3), are known to promote weight loss, which could be beneficial for treating obesity, and type 2 diabetes. Thyroid hormone treatment stimulates energy expenditure resulting in increased body heat production, in which brown adipose tissue play an important role. It is hypothesized that thyroid hormones would induce increased energy expenditure via a process called mitochondrial uncoupling, thereby creating an inefficient energy status. Indeed, an in vivo study showed a 70% increased flux through the tricarboxylic acid cycle (TCA) and an unchanged ATP synthesis rate upon T3 treatment in lean, healthy young men. The disproportionate increase in TCA flux compared with ATP synthesis suggests increased mitochondrial uncoupling. It is however unknown whether increased mitochondrial uncoupling would increase fat oxidation and exerts favorable effects on insulin sensitivity. There is compelling evidence that type 2 diabetic patients have high levels of fat accumulation in non-adipose tissues, such as skeletal muscle, heart and liver. Ectopic fat accumulation is related to insulin resistance, however, why this fat accumulates in peripheral organs is not known. Recently, studies reported compromised mitochondrial oxidative capacity in type 2 diabetic patients and first-degree relatives of diabetic patients, suggested to play an important role. Therefore, subjects suffering from overweight and/or type 2 diabetes with overt hypothyroidism form an interesting group for examining the metabolic effects of thyroid hormone treatment, as less is known about the effects of thyroid hormone treatment in these groups. Objective of the study: The purpose of this study is to evaluate whether thyroid hormone replacement therapy in type 2 diabetic patients suffering from overt hypothyroidism, will improve muscular mitochondrial function, lower ectopic fat accumulation in muscle and liver, increase brown adipose tissue activity and enhance insulin sensitivity. Study design: Type 2 diabetic patients diagnosed with hypothyroidism will undergo 3 months of thyroid hormone replacement therapy (THRT) (Euthyrox®, Merck, Germany). Patients will be metabolically characterized (such as insulin sensitivity and fat accumulation in peripheral tissues) before and after this thyroid hormone replacement therapy. Study population: 17 type 2 diabetic patients diagnosed with overt hypothyroidism (9 from the Netherlands, 8 from Germany which will only do the PET-CT) Primary study parameters/outcome of the study: Thyroid hormone-induced change in whole body insulin sensitivity (change in insulin-stimulated glucose disposal) and muscle mitochondrial function. Secondary study parameters/outcome of the study (if applicable): Thyroid hormone-induced change of lipid content in skeletal muscle and liver and brown adipose tissue activity.
NCT01458600 Adjuvant Treatment of Graves´ Ophthalmopathy With NSAID (aGO Study) Completed Mikael Lantz Phase 4 AGO study - adjuvant treatment, with NSAID, of endocrine ophthalmopathy in Graves´ disease Background - Already at diagnosis of Graves disease approximately 98% of the patients have morphological changes of the retrobulbar tissue concordant with ophthalmopathy. Factors known to induce clinical symptoms of ophthalmopathy are mainly unknown. An interesting observation is that a patient with stable and inactive Graves´ disease developed ophthalmopathy when treated with a glitazone due to diabetes type 2. Glitazones have been shown to increase differentiation of orbital preadipocytes to mature adipocytes. Glitazones are PPAR-gamma agonists and recently diclofenac have been shown to interact with PPAR-gamma in physiological concentrations. Other non-steroidal antiinflammatory drugs, NSAID, like indomethacin lack this effect. In addition, diclofenac inhibit synthesis of prostaglandins which also may be of importance because the natural ligand to PPAR-gamma is prostaglandin J. Inflammation and adipogenesis are hallmarks of the pathological process in Graves ophthalmopathy and NSAID like diclofenac may affect both. There is only one earlier study demonstrating effects of NSAID (indomethacin) in 7 patients with effects on soft tissue symptoms, eye muscle symptoms and eye protrusion. Aim - to investigate if diclofenac can prevent ophthalmopathy and/or progress of ophthalmopathy. Specific aims: 1. To study the frequency of clinical ophthalmopathy in Graves´ disease after 12 months treatment with or without diclofenac. 2. To study the frequency of progress of clinical signs and symptoms in ophthalmopathy after 12 months treatment with or without diclofenac. 3. To study the frequency of optic neuropathy in clinical ophthalmopathy after 12 months treatment with or without diclofenac. Study plan and randomisation - 150 patients with newly diagnosed Graves´disease without ophthalmopathy will be treated with anti-thyroid drugs and L-thyroxin (block and replace) according to clinical routine for 18 months. These patients will be randomized to diclofenac 50 mg twice daily or not for 12 months.
NCT01848171 Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism Active, not recruiting Shandong Provincial Hospital Phase 4 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.
NCT02512978 Reverse the HYpoTHyroid Status in Acute Myocardial InfarCtion (RHYTHMIC) Recruiting Beijing Anzhen Hospital Phase 4 Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.
NCT02512978 Reverse the HYpoTHyroid Status in Acute Myocardial InfarCtion (RHYTHMIC) Recruiting Beijing Chao Yang Hospital Phase 4 Based on accumulating evidences showing that hypothyroid status is associated with poor prognosis among acute myocardial infarction (AMI) patients, the study is designed to evaluate whether replacement treatment with levothyroxine could have beneficial effects on patients with AMI and hypothyroidism. This is a multicenter prospective computerized-randomized trial stratified by ejection fraction with a 1:1 ratio to levothyroxine group or standard therapy group.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Euthyrox

Condition Name

Condition Name for Euthyrox
Intervention Trials
Hypothyroidism 3
Heart Failure 1
Thyroid Diseases 1
Graves´ Disease 1
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Condition MeSH

Condition MeSH for Euthyrox
Intervention Trials
Hypothyroidism 5
Hyperthyroidism 1
Graves Ophthalmopathy 1
Heart Failure 1
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Clinical Trial Locations for Euthyrox

Trials by Country

Trials by Country for Euthyrox
Location Trials
China 3
Sweden 1
Netherlands 1
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Clinical Trial Progress for Euthyrox

Clinical Trial Phase

Clinical Trial Phase for Euthyrox
Clinical Trial Phase Trials
Phase 4 5
N/A 1
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Clinical Trial Status

Clinical Trial Status for Euthyrox
Clinical Trial Phase Trials
Completed 2
Recruiting 2
Active, not recruiting 1
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Clinical Trial Sponsors for Euthyrox

Sponsor Name

Sponsor Name for Euthyrox
Sponsor Trials
Chinese Academy of Medical Sciences, Fuwai Hospital 2
The Luhe Teaching Hospital of the Capital Medical University 2
The First Hospital of Hebei Medical University 1
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Sponsor Type

Sponsor Type for Euthyrox
Sponsor Trials
Other 17
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