Assessment of hypogonadism and its determinants among adult men with type 2 diabetes mellitus.

BACKGROUND AND AIMS: The impact of utilizing both symptoms as well as biochemically confirmed androgen deficiency in diagnosis of hypogonadism among type 2 diabetic men is relatively less studied. Furthermore, various determinants of hypogonadism in these men especially the role of insulin resistance and hypogonadism were studied. METHODS: This is a cross sectional study of 353 T2DM men aged 20-70 years of age. Hypogonadism was defined by taking both symptoms as well as calculated testosterone levels. Symptoms were defined using androgen deficiency in ageing male (ADAM) criteria. Various metabolic and clinical parameters were assessed and evaluated with regards to presence or absence of hypogonadism. RESULTS: Among 353 patients, 60 had both symptoms as well as biochemical evidence of hypogonadism. Assessment of calculated free testosterone but not total testosterone identified all such patients. Body mass index, HbA1c, fasting triglyceride level and HOMA IR inversely correlated with calculated free testosterone. We found that insulin resistance (HOMA IR) was independently associated with hypogonadism (odds ratio=1.108). CONCLUSION: Assessment of both symptoms of hypogonadism and calculated free testosterone represents a better way for correct identification of hypogonadal diabetic men. Insulin resistance has a strong association with hypogonadism independent of obesity and complication status of diabetes.

The prevalence and demographic determinants of blood donors receiving testosterone replacement therapy at a large USA blood service organization.

BACKGROUND: Blood donors receiving testosterone replacement therapy (TRT) often require therapeutic phlebotomy due to erythrocytosis. Red blood cells (RBCs) donated by eligible TRT donors are approved for collection and transfusion. This study was aimed at defining the prevalence and demographic determinants of TRT donors at a large USA blood service organization. STUDY DESIGN: Donation data from TRT donors and matched controls was collected from a de-identified electronic donor database across 16 blood centers in 2017-2018. Demographic determinants included race, sex, age, hemoglobin (Hb), body mass index (BMI), mean arterial pressure (MAP), and the frequency of donations in the 2-year period. RESULTS: TRT donors comprised 1.6% of the donor population and produced 2.2% of RBC units during 2018. TRT donors were likely to be middle-aged white or Hispanic men, with high prevalence of obesity (50.8% of TRT donors had BMI ≥30 kg/m2 compared with 36.2% in controls) and intensive donation frequency (1 to 29 donations in 2 years vs. 1 to 12 in controls). TRT donors had significantly (p < 0.0001) higher MAP and Hb compared with controls (MAP 99.9 ± 9.81 vs. 96.5 ± 10.1 mmHg; Hb 17.8 ± 1.44 vs. 15.6 ± 1.37 g/dL). One year of donations was associated with significant decreases in MAP and Hb for TRT donors. CONCLUSIONS: TRT is associated with high prevalence of erythrocytosis and obesity that may explain the intensive donation frequency, high MAP, and Hb. Frequent phlebotomies had a moderately positive effect on blood pressure and Hb levels. Potential implications of TRT on the quality of the RBC products require further evaluation.

Increased Medical Complications, Revisions, In-Hospital Lengths of Stay, and Cost in Patients With Hypogonadism Undergoing Primary Total Knee Arthroplasty.

BACKGROUND: Research regarding the impact of hypogonadism following primary total knee arthroplasty (TKA) is limited. Therefore, the purpose of this study is to investigate whether patients with hypogonadism undergoing primary TKA are at increased odds of (1) medical complications, (2) revisions, (3) in-hospital lengths of stay (LOSs), and (4) cost of care. METHODS: A Humana patient population consisting of 8 million lives was retrospectively analyzed from 2007 to 2017 using International Classification of Disease, 9th Revision codes. Patients were filtered by male gender and patients with hypogonadism were matched to controls in a 1:4 ratio according to age and medical comorbidities. The query yielded 8393 patients with (n = 1681) and without (6712) hypogonadism undergoing primary TKA. Primary outcomes analyzed included medical complications, revision rates, in-hospital LOS, and cost of care. Logistic regression analysis was used to calculate odds ratios (OR) of 90-day medical complications and 2-year revisions. Welch's t-test was used to test for significance in LOS and cost of care between cohorts. A P-value less than .05 was considered statistically significant. RESULTS: Hypogonadal patients undergoing primary TKA were found to have increased incidence and odds (9.45% vs 4.67%; OR 2.12, P < .0001) of developing 90-day medical complications. Hypogonadal patients undergoing primary TKA were found to have a greater incidence and odds (3.99% vs 2.80%; OR 1.89, P < .0001) of 2-year revisions. Hypogonadal patients had a 6.11% longer LOS (3.47 vs 3.27 days, P = .02) compared to controls, and incurred greater 90-day costs ($15,564.31 vs $14,856.69, P = .018) compared to controls. CONCLUSION: This analysis of over 1600 patients demonstrates that patients with hypogonadism undergoing primary TKA have greater odds of postoperative medical complications, revisions, increased LOS, and cost of care.

NAFLD in Some Common Endocrine Diseases: Prevalence, Pathophysiology, and Principles of Diagnosis and Management.

Secondary nonalcoholic fatty liver disease (NAFLD) defines those complex pathophysiological and clinical consequences that ensue when the liver becomes an ectopic site of lipid storage owing to reasons other than its mutual association with the metabolic syndrome. Disorders affecting gonadal hormones, thyroid hormones, or growth hormones (GH) may cause secondary forms of NAFLD, which exhibit specific pathophysiologic features and, in theory, the possibility to receive an effective treatment. Here, we critically discuss epidemiological and pathophysiological features, as well as principles of diagnosis and management of some common endocrine diseases, such as polycystic ovary syndrome (PCOS), hypothyroidism, hypogonadism, and GH deficiency. Collectively, these forms of NAFLD secondary to specific endocrine derangements may be envisaged as a naturally occurring disease model of NAFLD in humans. Improved understanding of such endocrine secondary forms of NAFLD promises to disclose novel clinical associations and innovative therapeutic approaches, which may potentially be applied also to selected cases of primary NAFLD.

A Clinical Perspective of Sleep and Andrological Health: Assessment, Treatment Considerations, and Future Research.

CONTEXT: Sleep that is insufficient, misaligned, or disrupted causes hypersomnolence and neuropsychological deficits, adversely affects cardiometabolic health, and is increasingly recognized to impair other biological processes that lead to conditions important to men, such as hypogonadism, erectile dysfunction, and infertility. EVIDENCE ACQUISITION: Literature review from 1970 to December 2018. EVIDENCE SYNTHESIS: High-quality and complementary epidemiological and interventional studies establish that abnormal sleep is associated with increased mortality, hypertension, and other cardiometabolic disorders (insufficient, disrupted, and misaligned sleep), as well as reduced fecundity and total sperm count (insufficient sleep), erectile dysfunction (disrupted sleep), and low testosterone (both). Circadian misalignment shifts the peak of testosterone's diurnal rhythm to occur soon after waking up, irrespective of the biological clock time, but it does not change the mean concentration. Preliminary studies show that extending sleep in individuals who are chronically sleep deprived may become a strategy to reduce insulin resistance and hypertension. Continuous positive airway pressure therapy can improve erectile function, and possibly systemic testosterone exposure, but only when used adherently by men with obstructive sleep apnea. Both high-dose and replacement-dose testosterone therapies modestly worsen sleep-disordered breathing, but they also improve cardiometabolic function and sexual desire. Persistence of either the adverse or beneficial outcomes over the longer term requires further investigation. CONCLUSIONS: Sleep is increasingly recognized to be essential for healthy living. Establishing the effect of abnormal sleep, and of improving sleep, on andrological issues of prime interest to men will promote prioritization of sleep, and may thereby improve overall long-term health outcomes.

Non-invasive DXA-derived bone structure assessment of acromegaly patients: a cross-sectional study.

Introduction Impaired bone microarchitecture is involved in vertebral fracture (VF) development among acromegaly patients. Aim of the study Comparison of DXA-derived bone parameters, areal BMD (aBMD), trabecular bone score (TBS) and 3D-SHAPER parameters in acromegaly patients with healthy controls. Methods This cross-sectional study evaluated acromegaly patients and a control group of healthy subjects. In all subjects, a single measurement of pituitary axis hormone levels, bone turnover markers, aBMD, (total hip (TH) and lumbar spine (LS)), TBS and 3D-SHAPER of the proximal femur region was performed. All subjects underwent DXA assessment of VF using the semiquantitative approach. Results One hundred six patients with acromegaly (mean age 56.6 years, BMI 30.2 kg/m2) and 104 control subjects (mean age 54.06 years, 28.4 BMI kg/m2) were included. After adjustment for weight, LS aBMD, TBS and TH trabecular volumetric BMD (vBMD) remained lower (P = 0.0048, <0.0001 and <0.0001, respectively) while cortical thickness (Cth) at TH and neck remained thicker (P = 0.006) in acromegaly patients compared with controls. The best multivariate model (model 1) discriminating patients with and without acromegaly included TBS, TH trabecular vBMD and TH Cth parameters (all P < 0.05). Twenty-two VFs (13 acromegaly subjects) were recognized. In these subjects after adjustment for age, FN aBMD, TH cortical sBMD and TH cortical vBMD remained significantly associated with the prevalent VF (OR = 2.69 (1.07-6.78), 2.84 (1.24-6.51) and 2.38 (1.11-5.10) for neck aBMD, TH cortical sBMD and TH cortical vBMD respectively)). The AUCs were similar for each parameter in this model. Conclusions Acromegaly patients, regardless of VF presence, have lower trabecular bone quantitative parameters, but those with VFs had decreased cortical density.

Short-term Assessment of HSCT Effects on the Hypothalamus-Pituitary Axis in Pediatric Thalassemic Patients.

BACKGROUND: Beta thalassemia major (BTM) and its treatment by hematopoietic stem cell transplantation (HSCT) may have deleterious effects on the endocrine systems. We assessed endocrine complications of HSCT in pediatric patients for 3 months. METHODS: In 20 (6 female) pediatric major thalassemic patients (mean age of 10.8 ± 3.9 years old), prolactin, luteinizing hormone (LH), follicle-stimulating hormone (FSH), T4, T3, thyroid-stimulating hormone (TSH), IGF-1, testosterone (in males) or estradiol (in females) were measured as a batch at the Endocrinology and Metabolism Research Center (EMRC) of Tehran University of Medical Sciences (TUMS) laboratories before HSCT and 1 and 3 months afterwards. The cosyntropin test for all and the clonidine test for short stature patients was conducted before HSCT. RESULTS: Before HSCT, delayed puberty and hypogonadotropic hypogonadism was found in 10% and 20% of patients, respectively. GH deficiency, low IGF1 and short stature was found in 25%, 55% and 40% of patients, respectively. Hypocortisolism, hypothyroidism and panhypopituitarism was found in 15%, 10% and 15% of patients, respectively. Prevalence of hypogonadotropic hypogonadism, low IGF1, hypothyroidism and panhypopituitarism was found in 20%, 40%, 10% and 10% of patients after 3 months, respectively (delayed puberty and short stature prevalence do not change after 3 months). HSCT caused lower T3 and estradiol and higher TSH. Corticosteroid users (15) had higher GH and lower T3 and testosterone or estradiol. Ferritin had a significant (negative) correlation with (before) prolactin and a significant correlation with T3 and T4 after HSCT. Age and acute graft-versus-host disease (GVHD) had no significant effect. CONCLUSION: Considering the small sample size and short duration of the study, it is difficult to reach any conclusion however it seems HSCT does not appear to have an overall positive or negative effect on prevalence of pituitary- hypothalamus axis disorders in pediatric thalassemic patients in 3 months.

Marketing and Testosterone Treatment in the USA: A Systematic Review.

CONTEXT: Testosterone replacement therapy (TRT) is currently approved by the Food and Drug Administration only for classic hypogonadism, although off-label indications have resulted in a dramatic expansion in prescriptions in the USA. Marketing may significantly affect prescriber behavior. OBJECTIVE: To systematically review all available evidence on marketing and TRT in the USA. EVIDENCE ACQUISITION: PubMed, Embase, and Scopus were searched up to July 2017 for all relevant publications reporting on assessments of the TRT market size, economic costs associated with hypogonadism, trends in TRT prescriptions, drug discontinuation rates, and advertising and sales efforts in the USA. EVIDENCE SYNTHESIS: Twenty retrospective studies were included in the final analysis. The market size for hypogonadism constitutes 5.6-76.8% of men in the USA, with the lower end of the range representing the strictest criteria for diagnosis. Men with a diagnosis of hypogonadism consume $14 118 in direct and indirect costs to the payer. Over the last 2 decades, TRT prescriptions have increased between 1.8- and 4-fold. After 1 yr, 80-85% of men discontinue TRT. There is an association between direct-to-consumer advertising and testosterone testing, TRT prescriptions, and TRT without testosterone testing. There is a high prevalence of misinformation on Internet advertising. CONCLUSIONS: Off-label indications have driven the dramatic expansion of TRT prescriptions over the last 2 decades. Direct-to-consumer advertising poses a unique challenge in the USA. Overtreatment can be avoided by applying strict diagnostic criteria for hypogonadism, which limits the addressable market for TRT. PATIENT SUMMARY: In this report, we reviewed the relationship between marketing and testosterone therapy in the USA. We found that many patients are prescribed testosterone without an appropriate diagnosis of hypogonadism, which may be related to the marketing efforts for off-label prescribing.

Metabolic syndrome in White-European men presenting for secondary couple's infertility: an investigation of the clinical and reproductive burden.

We aimed to determine the impact of metabolic syndrome (MetS) on reproductive function in men with secondary infertility, a condition that has received relatively little attention from researchers. Complete demographic, clinical, and laboratory data from 167 consecutive secondary infertile men were analyzed. Health-significant comorbidities were scored with the Charlson Comorbidity Index (CCI; categorised 0 vs 1 vs 2 or higher). NCEP-ATP III criteria were used to define MetS. Semen analysis values were assessed based on the 2010 World Health Organization (WHO) reference criteria. Descriptive statistics and logistic regression models tested the association between semen parameters and clinical characteristics and MetS. MetS was found in 20 (12%) of 167 men. Patients with MetS were older (P < 0.001) and had a greater BMI (P < 0.001) compared with those without MetS. MetS patients had lower levels of total testosterone (P = 0.001), sex hormone-binding globulin, inhibin B, and anti-Mόllerian hormone (all P ≤ 0.03), and they were hypogonadal at a higher prevalence (P = 0.01) than patients without MetS. Moreover, MetS patients presented lower values of semen volume, sperm concentration, and sperm normal morphology (all P ≤ 0.03). At multivariate logistic regression analysis, no parameters predicted sperm concentration, normal sperm morphology, and total progressive motility. Our data show that almost 1 of 8 White-European men presenting for secondary couple's infertility is diagnosed with MetS. MetS was found to be associated with a higher prevalence of hypogonadism, decreased semen volume, decreased sperm concentration, and normal morphology in a specific cohort of White-European men.

Is late-onset hypogonadotropic hypogonadism a specific age-dependent disease, or merely an epiphenomenon caused by accumulating disease-burden?

BACKGROUND: The aim of this paper is to summarize the available evidence supporting the link between late onset hypogonadism (LOH) and associated common clinical illnesses, focusing on metabolic diseases. The possible benefits or risks related to testosterone replacement therapy (TRT) in these conditions will also be analyzed. METHODS: An extensive Medline search was performed. RESULTS: LOH is closely associated with a worse metabolic profile and a higher cardiovascular risk. The relationship between hypogonadism obesity and insulin resistance is complex and bidirectional. Emerging evidence suggests a positive role of TRT in improving body composition and metabolic outcomes in subjects with LOH. CONCLUSIONS: Despite the aforementioned data, it is not completely known whether reduced testosterone levels in elderly males might play a direct pathogenetic role in these conditions or whether low T and associated morbidities are concomitant conditions, both associated with the aging process. Further and longer studies are advisable to confirm the preliminary results.

Testosterone prescribing in the population-a short social epidemiological analysis in Sweden.

PURPOSE: In recent years, there has been an increased interest for use of pharmaceutical testosterone among elderly men. However, it is still scarcely studied if this use is conditioned by socioeconomic factors in the general population of elderly men. METHODS: Using individual-level data from a population-based cohort of men aged 65-84 years in the County Scania, Sweden, we analysed testosterone use in 2006 in relation to demographic and socioeconomic factors by means of multiple logistic regression. We also analysed national data at the ecological level to investigate trends in prescribing between 2006 and 2014. RESULTS: The prevalence of testosterone use in Sweden among 65- to 84-year-old men increased by 83%, from 3.3 per 1000 men in 2006 to 6.0 in 2014. Testosterone use was more than twice as common in men in the highest income quintile compared with those in the lowest (0.68% versus 0.25%, odds ratio 2.69 and 95% confidence interval 1.80-4.02). Besides in the high-income group, testosterone use was highest in 65- to 69-year-old men, divorced men and, specially, in men with a previous hospital diagnose of hypogonadism. CONCLUSIONS: Our findings show socioeconomic inequities in prescription of testosterone. This is a short analysis based on limited data, but because information on this topic is scarce, our analysis adds a relevant piece of evidence and highlights the need for further research.

Risk of Venous Thromboembolism in Men Receiving Testosterone Therapy.

OBJECTIVE: To examine the risk of venous thromboembolism (VTE) associated with exposure to testosterone therapy in middle-aged and older men. PATIENTS AND METHODS: We conducted a case-control study of 30,572 men 40 years and older who were enrolled in one of the nation's largest commercial insurance programs between January 1, 2007, and December 31, 2012. Cases were defined as men who had a primary diagnosis of VTE and received an anticoagulant drug in the 60 days after their diagnoses. Cases were matched with 3 controls on event/index month, age, geographic region, diagnosis of hypogonadism, and diagnosis of any underlying prothrombotic condition. Conditional logistic regression analysis was used to calculate adjusted odds ratios (aORs) and 95% CIs for the risk of VTE associated with previous exposure to testosterone therapy. RESULTS: Exposure to testosterone therapy in the 15 days before the event/index date was not associated with an increased risk of VTE (aOR, 0.90; 95% CI, 0.73-1.12). None of the specific routes of administration examined were associated with an increased risk of VTE (topical [aOR, 0.80; 95% CI, 0.61-10.41], transdermal [aOR, 0.91; 95% CI, 0.38-2.16], and intramuscular [aOR, 1.15; 95% CI, 0.80-1.64]). These findings persisted using exposure windows that extended to 30 and 60 days before the event/index date. CONCLUSION: Having filled a prescription for testosterone therapy was not associated with an increased risk of VTE in commercially insured middle-aged and older men. These findings may provide clinically relevant information about the benefit-risk assessment for men with testosterone deficiency considering treatment.

Endocrinopathies, metabolic disorders, and iron overload in major and intermedia thalassemia: serum ferritin as diagnostic and predictive marker associated with liver and cardiac T2* MRI assessment.

INTRODUCTION: Endocrinopathies and metabolic disorders-characterized ß thalassemic (ßT) patients and the prevention and treatment of these comorbidities are important targets to be achieved. The aim of the study was to analyze the diagnostic and prognostic role of ferritin for endocrinopathies and metabolic disorders in ßT patients. The ability of iron chelators to treat iron overload and to prevent or reverse metabolic disorders and endocrinopathies was also evaluated. PATIENTS AND METHODS: Seventy-two ßT patients were treated with different chelation strategies during the study. Receiver operating characteristics analysis was employed to calculate the area under the curve for serum ferritin to find the best cutoff values capable of identifying endocrine dysfunction in thalassemic patients. Kaplan-Meier curves were generated to assess the incidence of endocrinopathy. Adjusted risk estimates for endocrinopathy were calculated using univariate followed by multivariate Cox proportional hazard regression analysis. RESULTS: High ferritin levels were observed in patients with hypothyroidism [1500 (872.5-2336.5) µg/L], hypogonadism [878 (334-2010) µg/L], and in patients with hypoparathyroidism or osteoporosis [834 (367-1857) µg/L]. A strict correlation between ferritin and T2* magnetic resonance imaging of heart (r = -0.64; P:0.0006) and liver (r = -0.40; P:0.03) values was observed. Patients with ferritin values above 1800 µg/L experienced a significantly faster evolution to hypothyroidism [log-rank (χ(2) ):7.7; P = 0.005], hypogonadism [log-rank (χ(2) ):10.7; P = 0.001], and multiple endocrinopathies [log-rank (χ(2) ):5.72; P = 0.02]. Ferritin predicted high risk of endocrine dysfunction independently of confounding factors (HR:1.23; P < 0.0001). The intensification of chelation therapy led to an amelioration of hypothyroidism. CONCLUSIONS: Ferritin represents a prognostic marker for ßT patients and a predictive factor for progression to endocrine dysfunctions. Intensive chelation therapy allows the reversibility of hypothyroidism.

Prevalence and influence of diagnostic criteria in the assessment of hypogonadism in intrathecal opioid therapy patients.

BACKGROUND: Hypogonadism is frequently diagnosed based on total testosterone (TT) levels alone. However, 99% of testosterone is bound to the sex hormone-binding globulin (SHBG) with only 1% free testosterone. Alternative assessment methods consist of assay of free testosterone (FT) or bioavailable testosterone (BT) by equilibrium dialysis, calculation of FT and BT through the Vermeulen equations, and calculation of the free androgen index (FAI). OBJECTIVES: The aim of this study was to investigate the prevalence of hypogonadism in male chronic non-cancer pain patients undertaking long-term intrathecal opioid therapy and the existence of diagnostic discrepancies according to the criteria used. STUDY DESIGN: Prospective observational study. SETTING: Department of Pain Management, Russells Hall Hospital, Dudley, United Kingdom. METHODS: Twenty consecutive male patients undertaking long-term intrathecal opioid therapy had the gonadal axis evaluated by assays of luteinising hormone (LH), follicle stimulating hormone (FSH), TT, SHBG and by calculating the FT, BT and FAI. RESULTS: Hypogonadism was present in 17 (85%) of the patients based on TT; 17 (85%) according to FT and BT calculations; and 14 (70%) when calculating FAI. Based on either TT or FT being low or borderline/low, 19 (95%) of the investigated patients were biochemically hypogonadal. Significant differences were observed between diagnosis based on FT and FAI (P < 0.05). No significant differences were observed between diagnosis based on TT and FT (P = 0.40) or TT and FAI (P = 0.20). CONCLUSION: Hypogonadism is common in patients undertaking intrathecal opioid therapy for the management of chronic non-malignant pain; however, diagnostic criteria can influence the diagnosis of this side effect. The assessment of the hypothalamic-pituitary-gonadal axis should include evaluation of total serum testosterone, free testosterone, or bioavailable testosterone.

The direct and indirect costs among U.S. privately insured employees with hypogonadism.

INTRODUCTION: While previous studies have noted that hypogonadism (HG) may pose a significant economic and quality-of-life burden, no studies have evaluated the impact of HG on healthcare utilization and costs in the United States. AIM: Compare direct (health care) and indirect (disability leave or medical absence) costs between privately insured U.S. employees with HG and controls without HG. METHODS: The study sample included 4,269 male employees, ages 35-64, with ≥ 2 HG diagnoses (International Classification of Diseases, Ninth Revision, Clinical Modification: 257.2x) or ≥ 1 HG diagnosis and ≥ 1 claim for testosterone therapy, 1/1/2005-3/31/2009, identified from a large, private insurance administrative database that includes medical, prescription drug, and disability claims data. The index date was the most recent HG diagnosis that had continuous eligibility for at least 1 year before (baseline period) and 1 year after (study period). Employees with HG were matched 1:1 on age, region, salaried vs. nonsalaried employment status, and index year to controls without HG. MAIN OUTCOME MEASURES: Descriptive analyses compared demographic characteristics, comorbidities, resource utilization, direct and indirect costs inflated to USD 2009. Multivariate analyses adjusting for baseline characteristics were used to estimate risk-adjusted costs. RESULTS: HG employees and controls had a mean age of 51 years. HG employees compared with controls had higher baseline comorbidity rates, including hyperlipidemia (50.2% vs. 25.3%), hypertension (37.7% vs. 21.1%), back/neck pain (32.0% vs. 15.7%), and human immunodeficiency virus/acquired immunodeficiency syndrome (7.1% vs. 0.3%) (all P < 0.0001). HG employees had higher mean study period direct ($10,914 vs. $3,823) and indirect costs ($3,204 vs. $1,450); HG-related direct costs were $832 (all P < 0.0001). Risk-adjusted direct ($9,291 vs. $5,248) and indirect ($2,729 vs. $1,840) costs were also higher for HG employees (all P < 0.0001). CONCLUSIONS: Employees with HG had higher comorbidity rates and costs compared with controls. Given the low HG-related costs, a primary driver of costs among HG patients appears to be their comorbidity burden.

Clinical assessment and validation of an Arabic Aging Male Symptoms questionnaire in patients with androgen deficiency.

AIM: To develop and to validate an Arabic Aging Male Symptoms (AMS) tool and to clinically assess patients with hypogonadism after hormonal treatment. METHODS: The tool was translated into Arabic and tested on 15 Saudi men. During a period of 9 months all males presented to the andrology clinic of the main University Hospital, King Saud University, Saudi Arabia with signs and symptoms of hypogonadism, were included in the study. Arabic AMS scale was applied in the base line visit, then 12 weeks after treatment. Testosterone was monitored before treatment, 4 weeks and after 12 weeks. RESULTS: Ninety-two subjects were included, Cronbach's α of 0.91 showed a very good internal consistency of the Arabic AMS questionnaire. The corresponding α for the subscales were 0.83, 0.84 and 0.73. There was a significant improvement in the mean level of TT after hormonal therapy (HT), this was reflected on the mean differences of improvement in the total Arabic AMS scores and subscales scores after HT, ranged from 31 to 35%. CONCLUSION: The present study revealed a significant association between testosterone levels and AMS tool manifested by a its good ability to measure the effect of treatment on quality of life for patients with hypogonadism.

Clinical and biochemical assessment of hypogonadism in men with type 2 diabetes: correlations with bioavailable testosterone and visceral adiposity.

OBJECTIVE: The aim of our study was to assess the prevalence of clinical hypogonadism, based on both symptoms and biochemical available measures of testosterone deficiency, in men with type 2 diabetes. RESEARCH DESIGN AND METHODS: In a cross-sectional study of 355 type 2 diabetic men aged >30 years, total and bioavailable testosterone, sex hormone-binding globulin, BMI, and waist circumference were measured and free testosterone was calculated. Overt hypogonadism was defined as the presence of clinical symptoms of hypogonadism and low testosterone level (total testosterone <8 nmol/l and/or bioavailable testosterone <2.5 nmol/l). Borderline hypogonadism was defined as the presence of symptoms and total testosterone of 8-12 nmol/l or bioavailable testosterone of 2.5-4 nmol/l. RESULTS: A low blood testosterone level was common in diabetic men, and a significant proportion of these men had symptoms of hypogonadism. Overt hypogonadism was seen in 17% of men with total testosterone <8 nmol/l and 14% with bioavailable testosterone <2.5 nmol/l. Borderline hypogonadism was found in 25% of men with total testosterone 8-12 nmol/l and bioavailable testosterone between 2.5 and 4 nmol/l; 42% of the men had free testosterone <0.255 nmol/l. BMI and waist circumference were both significantly negatively correlated with testosterone levels in men, with the association being stronger for waist circumference. CONCLUSIONS: Testosterone levels are frequently low in men with type 2 diabetes, and the majority of these men have symptoms of hypogonadism. Obesity is associated with low testosterone levels in diabetic men.

[Assessment of androgenic decline in the elderly]. / Comparación de distintos métodos para evaluar la función androgénica en el adulto mayor.

BACKGROUND: The gold standard to assess androgenic status is the measurement of free testosterone by equilibrium dialysis. However, the estimation of free testosterone using formulas based on the law of mass action can be an adequate standard. AIM: To assess androgenic decline in the elderly by different methods. MATERIAL AND METHODS: Free testosterone by radioimmunoassay, total testosterone and steroid binding globulin (SHBG) by automated chemiluminiscence system and estradiol by automated electrochemiluminiscence system were measured in 30 male aged 64+/-5 years (range 60-70), and 25 males aged between 20 and 30 years, as control group; devoid of diseases or drugs that could cause hypogonadism. Free androgen index, free testosterone, biavailable testosterone, and free estradiol were calculated using a formula based on the law of mass action. RESULTS: Fifty seven percent of elderly subjects had hypogonadism, according to calculated free testosterone values. Their total testosterone was on average, 152 nd/dl lower than in young adults, figure that represents a 3.8 ng/dl decline per year. According to total testosterone values, 27% of elderly males had gonadal incompetence. The correlations between calculated free testosterone and total testosterone was 0,95 and between calculated free testosterone and measured free testosterone was 0,67. The methods employed overestimated (76.7% of hypogonadism when using the free androgen index) or underestimated (27 and 3% of hypogonadism, considering total or free testosterone, respectively) the ondrogen decline of the elderly. Among the elderly, 16 or 30% of subjects had an absolute hypoestrogenism, based on estradiol or calculated free estradiol values, respectively. On average there was a 20 and 30% reduction of estradiol and calculated free estradiol values in the elderly. CONCLUSIONS: Calculated free or bioavailable testosterone values should be used to assess androgen decline in elderly men.

Comparación de distintos métodos para evaluar la función androgénica en el adulto mayor / Assessment of androgenic decline in the elderly

Background:The gold standard to assess androgenic status is the measurement of free testosterone by equilibrium dialysis. However, the estimation of free testosterone using formulas based on the law of mass action can be an adequate standard. Aim: To assess androgenic decline in the elderly by different methods. Material and methods: Free testosterone by radioimmunoassay, total testosterone and steroid binding globulin (SHBG) by automated chemiluminiscence system and estradiol by automated electrochemiluminiscence system were measured in 30 male aged 64±5 years (range 60-70), and 25 males aged between 20 and 30 years, as control group; devoid of diseases or drugs that could cause hypogonadism. Free androgen index, free testosterone, biavailable testosterone, and free estradiol were calculated using a formula based on the law of mass action. Results: Fifty seven percent of elderly subjects had hypogonadism, according to calculated free testosterone values. Their total testosterone was on average, 152 nd/dl lower than in young adults, figure that represents a 3.8 ng/dl decline per year. According to total testosterone values, 27 percent of elderly males had gonadal incompetence. The correlations between calculated free testosterone and total testosterone was 0,95 and between calculated free testosterone and measured free testosterone was 0,67. The methods employed overestimated (76.7 percent of hypogonadism when using the free androgen index) or underestimated (27 and 3 percent of hypogonadism, considering total or free testosterone, respectively) the ondrogen decline of the elderly. Among the elderly, 16 or 30 percent of subjects had an absolute hypoestrogenism, based on estradiol or calculated free estradiol values, respectively. On average there was a 20 and 30 percent reduction of estradiol and calculated free estradiol values in the elderly. Conclusions: Calculated free or bioavailable testosterone values should be used to assess androgen decline in elderly men.

Prevalence and management of mild hypogonadism: introduction.

Although male hypogonadism can adversely affect the well-being of otherwise healthy men, physicians sometimes overlook it as a possible contributing factor to decreased libido, erectile dysfunction (ED), irritability, osteoporosis, and decreased muscle mass. However, hypogonadism is easily treated by testosterone replacement therapy, which may provide benefits such as mood improvement, increased bone density, and possibly reduced risk of type II diabetes. Articles in this supplement focus on populations that may benefit from testosterone replacement therapy (eg, men with type II diabetes, HIV, and ED). An overview of male 'andropause' is also provided. The authors discuss the surprisingly high prevalence of hypogonadism in certain patient populations and its impact on quality of life. Although testosterone has been used therapeutically for years, much remains to be learn about this hormone and its positive effects.