scholarly journals Effects of Supraphysiological Doses of Levothyroxine on Sleep in Healthy Subjects: A Prospective Polysomnography Study

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Susanne Kraemer ◽  
Heidi Danker-Hopfe ◽  
Maximilian Pilhatsch ◽  
Frederik Bes ◽  
Michael Bauer
Keyword(s):  
Mood Disorders ◽  
Healthy Subjects ◽  
Statistical Significance ◽  
Maximum Tolerated Dose ◽  
Healthy Individuals ◽  
Sleep Structure ◽  
Open Label ◽  
Good Tolerability ◽  
Rem Density ◽  
Thyroid Hormone Levels

Disrupted sleep is prevalent in both mood and thyroid disorders. Given the emerging use of thyroid hormones in the treatment of mood disorders, we investigated the effects of supraphysiological doses of levothyroxine (L-T4) on sleep. In an open-label design, 13 healthy subjects received up to 500 μg/day for an eight-week period. A baseline night was polysomnographically recorded (PSG) followed by PSG under the maximum tolerated dose of L-T4. All subjects developed hyperthyroxinemia. The heart rate and respiration rate increased significantly with treatment; a significant increase in body temperature was observed in men but not in women. Surprisingly, treatment with supraphysiological doses of L-T4 did not cause significant effects on sleep architecture. However, the increase in body movements and REM density was close to reaching statistical significance. Here, we report on the sleep data, thyroid hormone levels, and physiological parameters during sleep. We conclude that experimentally induced hyperthyroidism does not profoundly change the sleep structure in healthy individuals underlining the good tolerability of treatment with supraphysiological doses of L-T4 in patients with mood disorders.

Deficient pulsatile thyrotropin secretion in the low-thyroid-hormone state of severe non-thyroidal illness

1994 ◽  
Vol 130 (2) ◽  
pp. 132-136 ◽  
Author(s):  
Nicola Custro ◽  
Vincenza Scafidi ◽  
Salvatore Gallo ◽  
Alberto Notarbartolo
Keyword(s):  
Thyroid Hormone ◽  
Healthy Subjects ◽  
Normal Subjects ◽  
Healthy Individuals ◽  
Circadian Variations ◽  
Tsh Secretion ◽  
Thyroid Hormone Levels ◽  
Rhythmic Change ◽  
Serum Tsh ◽  
Tsh Levels

Custro N, Scafidi V, Gallo S, Notarbartolo A. Deficient pulsatile thyrotropin secretion in the low-thyroid-hormone state of severe non-thyroidal illness. Eur J Endocrinol 1994;130:132–6. ISSN 0804–4643. Twenty-four-hour thyrotropin (TSH) profiles in eight severely ill patients were compared with those of six healthy subjects. The profiles were assessed using the cosinor method to evaluate circadian variations and using the Pulsar algorithm to analyze episodic secretion. In the normal subjects, the typical periodicity of TSH secretion showed a mean level in the rhythm (mesor) of 2.03 mU/l, The amplitude (half the extent of rhythmic change in the cycle) was 0.58 mU/l; the acrophase (the delay from midnight (0 degrees) of the highest level in the rhythm) was −9.9 degrees. In contrast, severely ill patients showed only slight and anticipated elevations of serum TSH levels (mesor 0.93 mU/l, amplitude 0.22 mU/l, acrophase +82.4 degrees). Moreover, whereas the episodic TSH secretion in healthy individuals consisted of 5–8 pulses/24 h, mainly clustered around midnight, only one pulse of reduced amplitude was detected in two of the eight severely ill patients and no pulses in the other six. Since earlier studies have indicated that the loss of TSH pulsatility is associated with the relative insensitivity of the thyrotrophs to low thyroid hormone levels and our analytical procedures have demonstrated that 24 h pulsatile pattern of TSH closely overlapped with baseline TSH secretion, it seems reasonable to assume that low-thyroid-hormone state, deficient pulsatile TSH secretion and altered nyctohemeral TSH periodicity do not coincide by chance, but that there is a causal relationship between such abnormalities in severely ill patients. Nicola Custro, Cattedra di Patologia Medica, Via del Vespro, n.141, 90127 Palermo, Italy

Pharmacokinetics and dopamine d2 and serotonin 5-ht2a receptor occupancy of paliperidone in healthy subjects: two open-label, single-dose studies (PAL-115)

2007 ◽  
Vol 40 (05) ◽  
Author(s):  
P Karlsson ◽  
L Hargarter ◽  
E Dencker ◽  
S Nyberg ◽  
E Mannaert ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Receptor Occupancy ◽  
Open Label ◽  
Dopamine D2

Effect of human galanin on the response of circulating catecholamines to hypoglycemia in man

1995 ◽  
Vol 133 (6) ◽  
pp. 723-728 ◽  
Author(s):  
Ettore C degli Uberti ◽  
Maria R Ambrosio ◽  
Marta Bondanelli ◽  
Giorgio Transforini ◽  
Alberto Valentini ◽  
...  
Keyword(s):  
Heart Rate ◽  
Healthy Subjects ◽  
Sympathetic Nerve Activity ◽  
Heart Rate Response ◽  
Statistical Significance ◽  
Inhibitory Effect ◽  
Amino Acid Residues ◽  
Nerve Activity ◽  
Receptor Stimulation

degli Uberti EC, Ambrosio MR, Bondanelli M, Trasforini G, Valentini A, Rossi R, Margutti A, Campo M. Effect of human galanin on the response of circulating catecholamines to hypoglycemia in man. Eur J Endocrinol 1995;133:723–8. ISSN 0804–4643 Human galanin (hGAL) is a neuropeptide with 30 amino acid residues that has been found in the peripheral and central nervous system, where it often co-exists with catecholamines. In order to clarify the possible role of hGAL in the regulation of sympathoadrenomedullary function, the effect of a 60 min infusion of hGAL (80 pmol·kg−1 · min−1) on plasma epinephrine and norepinephrine responses to insulin-induced hypoglycemia in nine healthy subjects was investigated. Human GAL administration significantly reduced both the release of basal norepinephrine and the response to insulin-induced hypoglycemia, whereas it attenuated the epinephrine response by 26%, with the hGAL-induced decrease in epinephrine release failing to achieve statistical significance. Human GAL significantly increased the heart rate in resting conditions and clearly exaggerated the heart rate response to insulin-induced hypoglycemia, whereas it had no effect on the blood pressure. We conclude that GAL receptor stimulation exerts an inhibitory effect on basal and insulin-induced hypoglycemia-stimulated release of norepinephrine. These findings provide further evidence that GAL may modulate sympathetic nerve activity in man but that it does not play an important role in the regulation of adrenal medullary function. Ettore C degli Uberti, Chair of Endocrinology, University of Ferrara, Via Savonarola 9, I-44100 Ferrara, Italy

A Comparative Evaluation of Serum and Salivary Total Proteins and Immunoglobulins in Patients with Hepatitis A and Healthy Subjects

2018 ◽  
Vol 69 (5) ◽  
pp. 1125-1128
Author(s):  
Daniela G. Balan ◽  
Dan Piperea Sianu ◽  
Iulia I. Stanescu ◽  
Dorin Ionescu ◽  
Andra Elena Stroescu Balcangiu ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Comparative Evaluation ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Point Of View ◽  
Healthy Individuals ◽  
Total Proteins ◽  
Statistical Point ◽  
Immunological Tests ◽  
Acute Hepatitis A

Assessment of changes in total proteins level, serum and saliva IgG and IgA levels, serum IgM level, serum and saliva IgA/IgG ratio. The study was conducted on a group of 40 subjects, divided into 2 lots: the first lot consisting of 20 healthy individuals and the second consisting of 20 patients with hepatitis with hepatitis A virus (HAV). The levels of total proteins, serum and saliva IgG and IgA, serum IgM and serum and saliva IgA/IgG ratio have higher values in patients with hepatitis A, in comparison to healthy subjects, without necessarily exceeding the maximum admitted value. The results are significant from a statistical point of view. Due to the sensitivity and specificity of salivary anti-HAV IgM and IgG in patients with acute hepatitis A, compared with healthy subjects, there is a possibility of using salivary immunological tests instead of serum tests for the diagnosis and epidemiological study of HAV infection.

Comparison of the Aditus ad Antrum Diameter on CT between Patients with Chronic Otitis Media and Healthy Individuals

2019 ◽  
Vol 15 (10) ◽  
pp. 990-993 ◽  
Author(s):  
Elif Gündoğdu ◽  
Uğur Toprak
Keyword(s):  
Computed Tomography ◽  
Otitis Media ◽  
Middle Ear ◽  
Healthy Subjects ◽  
Normal Values ◽  
Chronic Otitis Media ◽  
Healthy Individuals ◽  
Inner Diameter ◽  
Male Patients ◽  
The Right

Background: The middle ear cavity is ventilated through the aditus ad antrum. Aditus blockage contributes to the pathology of otitis media. Objective: To determine the normal values of the aditus ad antrum diameter on computed tomography and to investigate its relationship with chronic otitis media and related pathologies (tympanosclerosis and myringosclerosis). Methods: The temporal CT images of 162 individuals were evaluated retrospectively. In the axial sections, the inner diameter of the aditus was measured at the narrowest point at the cortex. The differences in diameter were compared between diseased and healthy ears. Results: In healthy individuals, the diameter was narrower in women. There was no difference between the right and left ears in healthy subjects. No correlation was found between age and diameter. In male patients with myringosclerosis, the diameter was slightly narrower on both sides but more marked on the left. In female patients with myringosclerosis, the diameter in both ears was slightly narrower. In cases of otitis media and tympanosclerosis, the diameter was less than that of healthy individuals, despite the lack of statistically significant result in all cases. Conclusion: The aditus ad antrum was narrower in diseased ears, indicating that a blocked aditus may contribute to the development of otitis media, as well as mucosal diseases.

Prevalence of Toxoplasma gondii and Toxocara canis among Myositis Patients in Southwest of Iran

2019 ◽  
Vol 20 ◽  
Author(s):  
Jasem Saki ◽  
Karim Mowla ◽  
Reza Arjmand ◽  
Forough Kazemi ◽  
Somayeh Fallahizadeh
Keyword(s):  
Toxoplasma Gondii ◽  
Nested Pcr ◽  
Healthy Subjects ◽  
Toxocara Canis ◽  
Control Group ◽  
Igg Antibodies ◽  
Healthy Individuals ◽  
High Prevalence ◽  
Acute Toxoplasmosis ◽  
Southwest Of Iran

Introduction: Parasitic myositis is caused by some parasites such as T. gondii and T. canis. So, the aim of the study was to evaluate the prevalence T. gondii and T. canis in patients with myositis and healthy individuals. Methods: A total of 108 samples were randomly selected as the control (54 healthy individuals) and test (54 myositis patients) groups. IgG and IgM antibodies against T. gondii and IgG antibodies against T. canis were measured by the ELISA. The detection of chronic and acute toxoplasmosis was performed by the ELISA IgG avidity. The presence of T. gondii in blood was evaluated by the nested-PCR. Results: Of 108, 33 (30.6%) cases were detected positive for IgG against T. gondii that 19 (35.2%) and 14 (25.9%) were observed in myositis patients and healthy individuals, respectively (P=0.296). Of 19 positive cases, 12 (63.2%) and 7 (36.8%) cases were detected as chronic and acute toxoplasmosis, respectively, while, all positive cases in the control group had chronic toxoplasmosis (P=0.013). One (1.9%) sample was detected positive for anti- Toxoplasma gondii IgM and two (3.7%) samples were found positive for IgG against T. canis by the ELISA that these positive cases were observed only in myositis patients (P=1.000 P=0.495, respectively). B1 T. gondii gene was amplified in 12 (63.2%) and 1 (7.1%) in myositis patients and healthy subjects (P=0.001). Conclusions: Our findings showed that there was a relatively high prevalence of acute toxoplasmosis in myositis patients in comparison with the control subjects in southwest of Iran.

Methylphenidate reduces orienting bias in healthy individuals

2021 ◽  
pp. 026988112199688
Author(s):  
Leehe Peled-Avron ◽  
Hagar Gelbard Goren ◽  
Noa Brande-Eilat ◽  
Shirel Dorman-Ilan ◽  
Aviv Segev ◽  
...  
Keyword(s):  
Healthy Subjects ◽  
Asymmetric Effect ◽  
Healthy Individuals ◽  
Double Blind ◽  
Spatial Orienting ◽  
Individual Trait ◽  
Neurological Patients ◽  
Dopamine Signaling ◽  
First Time ◽  
Neural Effect

Background: Healthy individuals show subtle orienting bias, a phenomenon known as pseudoneglect, reflected in a tendency to direct greater attention toward one hemispace. Accumulating evidence indicates that this bias is an individual trait, and attention is preferentially directed contralaterally to the hemisphere with higher dopamine signaling. Administration of methylphenidate (MPH), a dopamine transporter inhibitor, was shown to normalize aberrant spatial attention bias in psychiatric and neurological patients, suggesting that the reduced orienting bias following administration of MPH reflects an asymmetric effect of the drug, increasing extracellular dopamine in the hemisphere with lower dopamine signaling. Aim: We predicted that, similarly to its effect on patients with brain pathology, MPH will reduce the orienting bias in healthy subjects. Methods: To test this hypothesis, we examined the behavioral effects of a single dose (20 mg) of MPH on orienting bias in 36 healthy subjects (18 females) in a randomized, double-blind placebo-controlled, within-subject design, using the greyscales task, which has been shown to detect subtle attentional biases in both patients and healthy individuals. Results/outcomes: Results demonstrate that healthy individuals vary in both direction and magnitude of spatial orienting bias and show reduced magnitude of orienting bias following MPH administration, regardless of the initial direction of asymmetry. Conclusions/interpretations: Our findings reveal, for the first time in healthy subjects, that MPH decreases spatial orienting bias in an asymmetric manner. Given the well-documented association between orienting bias and asymmetric dopamine signaling, these findings also suggest that MPH might exert a possible asymmetric neural effect in the healthy brain.

scholarly journals A first-in-human, phase 1 study of the NEDD8 activating enzyme E1 inhibitor TAS4464 in patients with advanced solid tumors

2021 ◽  
Author(s):  
Noboru Yamamoto ◽  
Toshio Shimizu ◽  
Kan Yonemori ◽  
Shigehisa Kitano ◽  
Shunsuke Kondo ◽  
...  
Keyword(s):  
Liver Function ◽  
Solid Tumors ◽  
Dose Escalation ◽  
Enzyme Inhibitor ◽  
Phase 1 ◽  
Maximum Tolerated Dose ◽  
Primary Objective ◽  
Open Label ◽  
Phase 1 Study ◽  
Open Label Phase

SummaryBackground This open-label, phase 1 study investigated TAS4464, a potent NEDD8-activating enzyme inhibitor, in patients with advanced/metastatic solid tumors (JapicCTI-173,488; registered 13/01/2017). The primary objective was dose-limiting toxicities (DLTs). Maximum-tolerated dose (MTD) was investigated using an accelerated titration design. Methods The starting 10-mg/m2 dose was followed by an initial accelerated stage (weekly dosing; n = 11). Based on liver function test (LFT) results, a 14-day, 20-mg/m2 dose lead-in period was implemented (weekly dosing with lead-in; n = 6). Results Abnormal LFT changes and gastrointestinal effects were the most common treatment-related adverse events (AEs). DLTs with 56-mg/m2 weekly dosing occurred in 1/5 patients; five patients had grade ≥ 2 abnormal LFT changes at 40- and 56-mg/m2 weekly doses. Further dose escalation ceased because of the possibility of severe abnormal LFT changes occurring. DLTs with weekly dosing with lead-in occurred in 1/5 patients at a 56-mg/m2 dose; MTD could not be determined because discontinuation criteria for additional enrollment at that particular dose level were met. As no further enrollment at lower doses occurred, dose escalation assessment was discontinued. Serious treatment-related AEs, AEs leading to treatment discontinuation, and DLTs were all related to abnormal LFT changes, suggesting that TAS4464 administration could affect liver function. This effect was dose-dependent but considered reversible. Complete or partial responses to TAS4464 were not observed; one patient achieved prolonged stable disease. Conclusions MTD could not be determined due to TAS4464 effects on liver function. Further evaluation of the mechanism of NEDD8-activating enzyme inhibitor-induced abnormal liver function is required. Trial registration number JapicCTI-173,488 (registered with Japan Pharmaceutical Information Center). Registration date 13 January 2017

scholarly journals Preliminary Results of CitraVes™ Effects on Low Density Lipoprotein Cholesterol and Waist Circumference in Healthy Subjects after 12 Weeks: A Pilot Open-Label Study

Metabolites ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. 276
Author(s):  
Stefania Raimondo ◽  
Dragana Nikolic ◽  
Alice Conigliaro ◽  
Gianluca Giavaresi ◽  
Bruna Lo Sasso ◽  
...  
Keyword(s):  
Risk Factors ◽  
Healthy Subjects ◽  
Cardiometabolic Risk ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Modifiable Risk Factors ◽  
Low Density Lipoprotein Cholesterol ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

Appropriate monitoring and control of modifiable risk factors, such as the level of low-density lipoprotein cholesterol (LDL-C) and other types of dyslipidemia, have an important role in the prevention of cardiovascular diseases (CVD). Recently, various nutraceuticals with lipid-lowering effects have gained attention. In addition to the plant-derived bioactive compounds, recent studies suggested that plant cells are able to release small lipoproteic structures named extracellular vesicles (EVs). The interaction between EVs and mammalian cells could lead to beneficial effects through anti-inflammatory and antioxidant activities. The present study aimed to assess the safety of the new patented plant-based product citraVes™, containing extracellular vesicles (EVs) from Citrus limon (L.) Osbeck juice, and to investigate its ability to modulate different CV risk factors in healthy subjects. A cohort of 20 healthy volunteers was recruited in a prospective open-label study. All participants received the supplement in a spray-dried formulation at a stable dose of 1000 mg/day for 3 months. Anthropometric and hematobiochemical parameters were analyzed at the baseline and after the follow-up period of 1 and 3 months. We observed that the supplement has an effect on two key factors of cardiometabolic risk in healthy subjects. A significant change in waist circumference was found in women after 4 (85.4 [79.9, 91.0] cm, p < 0.005) and 12 (85.0 [80.0, 90.0] cm, p < 0.0005) weeks, when compared to the baseline value (87.6 [81.7, 93.6] cm). No difference was found in men (baseline: 100.3 [95.4, 105.2] cm; 4 weeks: 102.0 [95.7, 108.3] cm; 12 weeks: 100.0 [95.3, 104.7] cm). The level of LDL-C was significantly lower at 12 weeks versus 4 weeks (p = 0.0064). Our study evaluated, for the first time, the effects of a natural product containing plant-derived EVs on modifiable risk factors in healthy volunteers. The results support the use of EV extracts to manage cardiometabolic risk factors successfully.

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