Dataset Information

Seasonal Changes of Serum Gonadotropins and Testosterone in Men Revealed by a Large Data Set of Real-World Observations Over Nine Years.

ABSTRACT: Environmental rhythmicity is able to affect the hypothalamic-pituitary-gonadal axis in several animals to achieve reproductive advantages. However, conflicting results were obtained when assessing the environmental-dependent rhythmicity on reproductive hormone secretion in humans. This study was designed to evaluate seasonal fluctuations of the main hormones involved in the hypothalamic-pituitary-gonadal axis in men, using a big data approach. An observational, retrospective, big data trial was carried out, including all testosterone, luteinizing hormone (LH) and follicle-stimulating hormone (FSH) measurements performed in a single laboratory between January 2010 and January 2019 using Chemiluminescent Microparticle Immunoassay. Subjects presenting any factor interfering with the hypothalamic-pituitary-gonadal axis were excluded. The trend and seasonal distributions were analyzed using autoregressive integrated moving average (ARIMA) models. A total of 12,033 data, accounting for 7,491 men (mean age 47.46 ± 13.51 years, range 18-91 years) were included. Testosterone serum levels (mean 5.34 ± 2.06 ng/dL, range 1.70-15.80 ng/dL) showed a seasonal distribution with higher levels in summer and a direct correlation to environmental temperatures and daylight duration. LH levels (mean 4.64 ± 2.54 IU/L, range 1.00-15.00 IU/L) presented 2 peaks of secretion in autumn and spring, independently from environmental parameters. FSH levels (mean 5.51 ± 3.24 IU/L) did not show any seasonal distribution. A clear seasonal fluctuation of both LH and testosterone was demonstrated in a large cohort of adult men, although a circannual seasonality of hypothalamic-pituitary-gonadal hormones in humans could be not strictly evolutionarily required. Testosterone seasonality seems independent from LH fluctuations, which could be regulated by cyclic central genes expression, and more sensible to environmental temperatures and daylight duration.

SUBMITTER: Santi D

PROVIDER: S-EPMC6965064 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Seasonal Changes of Serum Gonadotropins and Testosterone in Men Revealed by a Large Data Set of Real-World Observations Over Nine Years.

Santi Daniele D Spaggiari Giorgia G Granata Antonio R M ARM Setti Monica M Tagliavini Simonetta S Trenti Tommaso T Simoni Manuela M

Frontiers in endocrinology 20200110

Environmental rhythmicity is able to affect the hypothalamic-pituitary-gonadal axis in several animals to achieve reproductive advantages. However, conflicting results were obtained when assessing the environmental-dependent rhythmicity on reproductive hormone secretion in humans. This study was designed to evaluate seasonal fluctuations of the main hormones involved in the hypothalamic-pituitary-gonadal axis in men, using a big data approach. An observational, retrospective, big data trial was ...[more]

PMID: 31998242

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Project description:Background The prevalence of low testosterone levels in men increases with age, as does the prevalence of decreased mobility, sexual function, self-perceived vitality, cognitive abilities, bone mineral density, and glucose tolerance, and of increased anemia and coronary artery disease. Similar changes occur in men who have low serum testosterone concentrations due to known pituitary or testicular disease, and testosterone treatment improves the abnormalities. Prior studies of the effect of testosterone treatment in elderly men, however, have produced equivocal results. Purpose To describe a coordinated set of clinical trials designed to avoid the pitfalls of prior studies and to determine definitively whether testosterone treatment of elderly men with low testosterone is efficacious in improving symptoms and objective measures of age-associated conditions. Methods We present the scientific and clinical rationale for the decisions made in the design of this set of trials. Results We designed The Testosterone Trials as a coordinated set of seven trials to determine if testosterone treatment of elderly men with low serum testosterone concentrations and symptoms and objective evidence of impaired mobility and/or diminished libido and/or reduced vitality would be efficacious in improving mobility (Physical Function Trial), sexual function (Sexual Function Trial), fatigue (Vitality Trial), cognitive function (Cognitive Function Trial), hemoglobin (Anemia Trial), bone density (Bone Trial), and coronary artery plaque volume (Cardiovascular Trial). The scientific advantages of this coordination were common eligibility criteria, common approaches to treatment and monitoring, and the ability to pool safety data. The logistical advantages were a single steering committee, data coordinating center and data and safety monitoring board, the same clinical trial sites, and the possibility of men participating in multiple trials. The major consideration in participant selection was setting the eligibility criterion for serum testosterone low enough to ensure that the men were unequivocally testosterone deficient, but not so low as to preclude sufficient enrollment or eventual generalizability of the results. The major considerations in choosing primary outcomes for each trial were identifying those of the highest clinical importance and identifying the minimum clinically important differences between treatment arms for sample size estimation. Potential limitations Setting the serum testosterone concentration sufficiently low to ensure that most men would be unequivocally testosterone deficient, as well as many other entry criteria, resulted in screening approximately 30 men in person to randomize one participant. Conclusion Designing The Testosterone Trials as a coordinated set of seven trials afforded many important scientific and logistical advantages but required an intensive recruitment and screening effort.

Dataset Information

Seasonal Changes of Serum Gonadotropins and Testosterone in Men Revealed by a Large Data Set of Real-World Observations Over Nine Years.

Publications

Seasonal Changes of Serum Gonadotropins and Testosterone in Men Revealed by a Large Data Set of Real-World Observations Over Nine Years.

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