Tag Archives: #testosterone

Men With Low Testosterone More Likely to Die From Covid-19 (Medicine)

Men with symptomatic Covid-19, who were found to have low testosterone following admittance to hospital, were more likely to become severely ill and die from the disease, new research has shown.

The study, carried out in Milan during the first wave of coronavirus in 2020, found that the lower the levels of testosterone, the higher the likelihood that male patients would need intensive care, be intubated on a ventilator and remain in hospital over a longer period. Their likelihood of dying increased six-fold.

The findings are being presented at the European Association of Urology congress, EAU21, which runs this week from July 8-12.

Professor Andrea Salonia and his colleagues at the San Raffaele University Hospital in Milan compared 286 male Covid patients, who came to the emergency department, with 305 healthy male volunteers, who attended hospital to give blood between Feb and May 2020.

The team checked both patients and volunteers for levels of male hormones, including testosterone. Testosterone is measured in nanomoles per litre (nmol/l) and 9.2 or below is deemed the threshold for low testosterone, termed hypogonadism.

Nearly 90 per cent of the patients had testosterone below this level, compared to just 17 per cent of the healthy volunteers. Furthermore, testosterone levels in the patients were also significantly below the threshold, averaging around 2.5 nmol/l.

Those patients who had mild symptoms or were admitted to hospital had slightly higher testosterone levels (between 3-4 nmol/l) than those admitted to ICU or those who died of the disease (just 0.7-1.0 nmol/l).

Even when age, pre-existing conditions and body mass index (BMI) were taken into account, the differences in hormonal profiles and clinical outcomes were still stark.

Professor Salonia, a specialist in urology and endocrinology at San Raffaele Hospital, says:

“At the start of the Covid pandemic, we were seeing far more men than women coming to hospital and suffering very severe forms of the disease. We immediately thought this might be related to male hormone levels, particularly testosterone.

“But we never expected to see such a high proportion of Covid patients with these extremely low levels of testosterone, in comparison to a similar group of healthy men. The relationship is very clear: the lower the testosterone, the higher the severity of the condition and likelihood of death. I’ve never seen anything like it in my 25 years in the field.”

Because the team does not have data on the testosterone levels in the patients before they contracted Covid-19, they cannot say whether low testosterone was a pre-existing long-term condition that exacerbated the disease or whether it was caused by the SARS-COV2 virus.

However, other research has shown that some receptors for the virus, including the enzyme TMPRSS2, are linked to male hormones and that the virus reduces the number of Leydig cells in the body, which produce testosterone

“We simply don’t have the data to know which came first in these patients, the low testosterone levels or the Covid,” explains Professor Salonia. “Testosterone does play a role in protecting men from disease. However, it’s also possible that the virus itself is able to induce an acute reduction in testosterone levels, which then predisposes these men to a worse outcome. We’re now following up these patients over a longer time period, to see how their hormone levels change over time, so we can try and answer these questions.”

The annual EAU congress is Europe’s biggest urology conference, bringing together clinicians, scientists and patients to discuss the latest research and medical developments linked to the urinary tract and male reproductive system. EAU21 takes place virtually this year, due to Covid restrictions.

Professor Jens Sonksen, a member of the EAU Executive, said: “The SARS-CoV-2 pandemic has had a tremendous impact on global health since the virus first started spreading in early 2020. We have learned a lot about the virus and possible health consequences from COVID-19 since those early days, but there is much still to learn. This is highlighted by this new research, which found a surprisingly low level of total testosterone in men with COVID-19 compared to healthy controls. Symptomatic COVID-19 patients with low testosterone were also more likely to become critically ill from COVID-19. Additional research on potential impacts from COVID-19 on men’s health is definitely needed.”


This science news has been confirmed by us from EAU


Provided by EAU

Testosterone Therapy May Reduce Non-alcoholic Fatty Liver Disease in Obese (Medicine)

According to a new study, testosterone therapy may reduce non-alcoholic fatty liver disease in obese men with functional hypogonadism and type-2 diabetes.

Testosterone therapy may help obese men with functional hypogonadism and type-2 diabetes reduce the prevalence of non-alcoholic fatty liver disease (NAFLD), according to a study being presented at the 23rd?European Congress of Endocrinology (e-ECE 2021), on Tuesday 25 May 2021 at 14:00 CET (http://www.ece2021.org). The two-year study found that therapy with testosterone undecanoate normalised testosterone levels, reduced NAFLD, and suppressed the symptoms of hypogonadism in men living with these conditions.

NAFLD is emerging as a public health issue worldwide. It is estimated that prevalent cases will increase 21% by 2030, from 83.1 million to 100.9 million. NAFLD is more commonly found in people with type-2 diabetes, and is linked to obesity, insulin resistance and atherogenic dyslipidemia. NAFLD refers to excess fat accumulation in the liver, in the absence of excessive alcohol consumption. Alcohol consumption of less than 30 g (3.75 units) per day for men is used as the cut-off to diagnose NAFLD. As an increasing global health issue, this study and its findings may be a promising area for further research.

Dr Kristina Groti Antonic and her team from the University of Ljubljana, Slovenia, carried out a large study on the effects of testosterone therapy on glycemic control, metabolic parameters, vascular function and morphology in obese men with hypogonadism and type-2 diabetes mellitus. They presented a part of this study at e-ECE 2021 in which they evaluated the effects of testosterone therapy on morphology and grade of NAFLD in this population. The two-year clinical trial saw 55 males with functional hypogonadism and type-2 diabetes participate. The first year focused on a double blind, placebo-controlled study and the following year was used for follow-up.

During the study, the participants were randomised into two groups. The first group received testosterone undecanoate during both years of the study, while the second group received a placebo in the first year and testosterone therapy in the second year. A range of tests including testosterone levels, prostate specific antigen and routine blood tests were assessed at the beginning of the trial, 12 and 24 months. Liver ultrasounds for NAFLD grade assessments were performed at the beginning and after two years, which showed an improvement in NAFLD grades after two years of the trial.

Dr Kristina Groti Antonic shared that, “improvement of NAFLD grade was a result of improved insulin resistance, reduction in body mass index and body weight, along with changes in body composition. As we know, testosterone increases lean body mass at the expense of fat mass, either alone or in combination with behavioral and lifestyle modifications. Testosterone with its anti-inflammatory effects also reduced chronic inflammatory state in the liver. Our study shows that testosterone therapy could be used as a suitable therapy for obese men living with non-alcoholic fatty liver disease, and therefore the findings can be used to tackle this growing pandemic.”

This knowledge could help obese men living with functional hypogonadism and type-2 diabetes experience normalised testosterone levels and reduced prevalence of non-alcoholic fatty liver disease.

The study, “Effects of testosterone therapy on morphology and grade of NAFLD in obese men with functional hypogonadism and type 2 diabetes”, appeared in Endocrine Abstracts (2021) 73 PEP7.1 | DOI: 10.1530/endoabs.73.PEP7.1


Provided by European Society of Endocrinology

For Men, Low Testosterone Means High Risk of Severe COVID-19 (Medicine)

New clues on why more men than women develop severe disease

Throughout the pandemic, doctors have seen evidence that men with COVID-19 fare worse, on average, than women with the infection. One theory is that hormonal differences between men and women may make men more susceptible to severe disease. And since men have much more testosterone than women, some scientists have speculated that high levels of testosterone may be to blame.

But a new study from Washington University School of Medicine in St. Louis suggests that, among men, the opposite may be true: that low testosterone levels in the blood are linked to more severe disease. The study could not prove that low testosterone is a cause of severe COVID-19; low levels could simply serve as a marker of some other causal factors. Still, the researchers urge caution with ongoing clinical trials investigating hormonal therapies that block or lower testosterone or increase estrogen as a treatment for men with COVID-19.

The study appears online May 25 in JAMA Network Open.

“During the pandemic, there has been a prevailing notion that testosterone is bad,” said senior author Abhinav Diwan, MD, a professor of medicine. “But we found the opposite in men. If a man had low testosterone when he first came to the hospital, his risk of having severe COVID-19 — meaning his risk of requiring intensive care or dying — was much higher compared with men who had more circulating testosterone. And if testosterone levels dropped further during hospitalization, the risk increased.”

The researchers measured several hormones in blood samples from 90 men and 62 women who came to Barnes-Jewish Hospital with symptoms of COVID-19 and who had confirmed cases of the illness. For the 143 patients who were admitted to the hospital, the researchers measured hormone levels again at days 3, 7, 14 and 28, as long as the patients remained hospitalized over these time frames. In addition to testosterone, the investigators measured levels of estradiol, a form of estrogen produced by the body, and IGF-1, an important growth hormone that is similar to insulin and plays a role in maintaining muscle mass.

Among women, the researchers found no correlation between levels of any hormone and disease severity. Among men, only testosterone levels were linked to COVID-19 severity. A blood testosterone level of 250 nanograms per deciliter or less is considered low testosterone in adult men. At hospital admission, men with severe COVID-19 had average testosterone levels of 53 nanograms per deciliter; men with less severe disease had average levels of 151 nanograms per deciliter. By day three, the average testosterone level of the most severely ill men was only 19 nanograms per deciliter.

The lower the levels of testosterone, the more severe the disease. For example, those with the lowest levels of testosterone in the blood were at highest risk of going on a ventilator, needing intensive care or dying. Thirty-seven patients — 25 of whom were men — died over the course of the study.

The researchers noted that other factors known to increase the risk of severe COVID-19, including advanced age, obesity and diabetes, also are associated with lower testosterone. “The groups of men who were getting sicker were known to have lower testosterone across the board,” said first author Sandeep Dhindsa, MD, an endocrinologist at Saint Louis University. “We also found that those men with COVID-19 who were not severely ill initially, but had low testosterone levels, were likely to need intensive care or intubation over the next two or three days. Lower testosterone levels seemed to predict which patients were likely to become very ill over the next few days.”

In addition, the researchers found that lower testosterone levels in men also correlated with higher levels of inflammation and an increase in the activation of genes that allow the body to carry out the functions of circulating sex hormones inside the cells. In other words, the body may be adapting to less testosterone circulating in the bloodstream by dialing up its ability to detect and use the hormone. The researchers don’t yet know the implications of this adaptation and are calling for more research.

“We are now investigating whether there is an association between sex hormones and cardiovascular outcomes in long COVID-19, when the symptoms linger over many months,” said Diwan, who is a cardiologist. “We also are interested in whether men recovering from COVID-19, including those with long COVID-19, may benefit from testosterone therapy. This therapy has been used in men with low levels of sex hormones, so it may be worth investigating whether a similar approach can help male COVID-19 survivors with their rehabilitation.”

This study used Washington University’s COVID-19 biorepository and was conducted as a collaboration of the university’s Institute of Clinical and Translational Sciences (ICTS), which includes Saint Louis University School of Medicine.

This work was supported by the National Institutes of Health (NIH), grant numbers R37 AI049653, P30 DK020579, HL107594 and HL143431; and a grant from The Foundation for Barnes-Jewish Hospital to facilitate data collection from the WU350 cohort, which supported these studies. These studies also were supported by the Washington University Institute of Clinical and Translational Sciences, grant number UL1TR002345 from the National Center for Advancing Translational Sciences (NCATS) of the NIH.

Featured image: A new study from Washington University School of Medicine in St. Louis suggests that, among men, low testosterone levels in the blood are linked to more severe COVID-19. The study contradicts widespread assumptions that higher testosterone may explain why men, on average, develop more severe COVID-19 than women do. © Sara Moser


Reference: Dhindsa S, Zhang N, McPhaul MJ, Wu Z, Ghoshal AK, Erlich EC, Mani K, Randolph GJ, Edwards JR, Mudd PA, Diwan A. Relationship of circulating sex hormones with inflammation and disease severity in COVID-19. JAMA Network Open. May 25, 2021.


Provided by Washington University School of Medicine at St. Louis

Testosterone May Act As ‘Brake Pedal’ On Immune Response, Protect Men From Stomach Inflammation (Medicine)

Autoimmune diseases have something in common with horses, bachelor’s degrees and daily flossing habits: women are more likely to have them.

One reason for autoimmune diseases’ prevalence in women may be sex-based differences in inflammation. In a new study, West Virginia University researcher Jonathan Busada investigated how sex hormones affect stomach inflammation in males and females. He found that androgens—or male sex hormones—may help to keep stomach inflammation in check. 

“Stomach cancer is primarily caused by rampant inflammation,” said Busada, an assistant professor in the School of Medicine and researcher with the Cancer Institute. “The overarching theme of my lab is to understand what’s controlling the balance between a protective immune response, which is just targeting the infection, and a pathogenic immune response, which is like a toddler throwing a temper tantrum and damaging everything. It looks like androgens may be really important in tipping that balance toward a protective response.”

His findings appear in Gastroenterology.

Busada’s study focused on testosterone, the primary male sex hormone.

The study also considered glucocorticoids—steroid hormones that the adrenal glands secrete. Unlike testosterone, glucocorticoids are not sex hormones. Their production doesn’t differ substantially between women and men.

Glucocorticoids are “the chief anti-inflammatory hormones that your body produces,” Busada said. “You can think of them as the brake pedal to the immune system.”

In researching mice without either glucocorticoids or testosterone, Busada, his research partner John Cidlowski—a senior investigator with the National Institutes of Health—and their colleagues observed that males’ stomach inflammation increased as much as the females’ did.

What’s more, when he and his team gave testosterone to the female mice, their inflammation vanished.

“We were able to completely rescue them from their stomach inflammation,” Busada said. “We proved that androgens were the hormones giving male mice that double layer of protection from inflammation. In the females, the only anti-inflammatory hormone was glucocorticoids. In males, it could be either glucocorticoids or androgens. This study potentially explains why women have a much higher incidence of autoimmune and chronic inflammatory diseases.”

For instance, celiac disease is two to three times as common in women as in men. Multiple sclerosis and rheumatoid arthritis are three times as common. Thyroid problems? Five to eight times.

“Actually, eight out of 10 individuals with autoimmune disease are women,” Busada said.

Based on these research findings, clinicians may consider if disruptive glucocorticoid or androgen signaling is contributing to their patients’ stomach-inflammatory diseases.

“If someone presents with stomach inflammation, it might be worth it for clinicians to investigate what’s going on with their endocrine system,” Busada said.

And that’s not only the case if the patient is a woman. Even though women are more susceptible to chronic stomach-inflammatory diseases, men are more susceptible to stomach cancer, of which inflammation is the biggest cause. 

Worldwide, stomach cancer is the fifth most common form of cancer and the third leading cause of cancer deaths.

“Persistent, smoldering inflammation over the course of many, many years is the fertile ground for stomach cancer to grow.” Busada said. “It’s an important, and understudied, human health issue.”

“These findings may help us understand how inflammation promotes cancer development, but we can’t make any direct inferences about stomach cancer from this body of work,” he said. “That’s the direction we’re moving in, though. We’re currently studying how sex affects carcinogenesis using an actual cancer model.”

Featured image: Jonathan Busada—a researcher with the WVU School of Medicine and Cancer Institute—has investigated the role that hormones play in male and female inflammatory responses. In a new animal study, he found that testosterone may protect against stomach inflammation. His findings appear in the journal Gastroenterology. (WVU Photo/Brian Persinger)


Reference:

Title: Glucocorticoids and androgens protect from gastric metaplasia by suppressing group 2 innate lymphoid cell activation DOI: https://doi.org/10.1053/j.gastro.2021.04.075 Link: https://www.gastrojournal.org/article/S0016-5085(21)00750-2/fulltext#%20


Provided by WVU Today

Inflammatory Diet Linked to Testosterone Deficiency in Men (Medicine)

April 21, 2021 – Consuming a diet high in pro-inflammatory foods – including foods that contain refined carbohydrates and sugar as well as polyunsaturated fats – may be associated with increased odds of developing testosterone deficiency among men, suggests a study in The Journal of Urology®, Official Journal of the American Urological Association (AUA). The journal is published in the Lippincott portfolio by Wolters Kluwer.

The risk of testosterone deficiency is greatest in men who are obese and consume a refined diet that scores high on the dietary inflammatory index (DII), according to the new research by Qiu Shi, MD, Zhang Chichen, MD, and colleagues of West China Hospital, Sichuan University, Chengdu, Sichuan Province, China. “While these findings do not prove causation, they do support previous research suggesting a pro-inflammatory diet can contribute to testosterone deficiency, among other potentially debilitating health issues,” Drs. Qiu and Zhang comment.

Does diet influence testosterone levels? New study discovers link

Testosterone is a male sex hormone that plays important roles in reproduction and sexual function. However, 20 to 50 percent of US men have testosterone deficiency – defined as a testosterone level less than 300 ng/dL (nanograms per deciliter). Symptoms of testosterone deficiency may include low libido, decreased energy, poor concentration and depression. Testosterone deficiency is also associated with chronic diseases, including cardiovascular disease and obesity.

Human and animal studies have linked testosterone deficiency with increased levels of inflammation in the body. Men with low testosterone have higher levels of pro-inflammatory cytokines: small proteins released by cells during injury, infection or in response to inflammatory factors in the environment. The DII has emerged as a tool for assessing the inflammatory potential of a person’s diet, particularly in relation to other markers of health.

The researchers studied the association between the DII and testosterone deficiency in 4,151 men from the National Health and Nutrition Examination Survey, all of whom completed a 24-hour dietary interview and underwent sex hormone testing. Each participant’s DII was calculated based on the dietary history interview.

Calculated DII scores ranged from ?5.05 (most anti-inflammatory) to +5.48 (most pro-inflammatory). Average total testosterone level was 410.42 ng/dL in men with the most pro-inflammatory diet versus 422.71 ng/dL in those with the most anti-inflammatory diet. Overall, about 26 percent of the men had testosterone deficiency.

For men with the most pro-inflammatory diet, the odds of testosterone deficiency were about 30 percent higher compared to men with the most anti-inflammatory diet. The associations remained significant after adjustment for other characteristics, including body mass index and smoking.

In a fully adjusted analysis, the risk of testosterone deficiency was greatest in men who were obese and had a higher DII. For this group, the odds of testosterone deficiency were nearly 60 percent higher compared to men with obesity who had a lower DII.

Drs. Qiu, Zhang, and coauthors note some important limitations of their study, including the fact that the DII was calculated based on a limited number of anti-inflammatory and pro-inflammatory food parameters.

“Our results suggest men who eat a pro-inflammatory diet, particularly those who are obese, are more likely to have testosterone deficiency,” Drs. Qiu and Zhang comment. “Since men with obesity likely already experience chronic inflammation, physicians should be aware of contributing factors, like diet, that could likely worsen this inflammation and contribute to the risk of other health conditions, such as diabetes and heart disease.”

Drs. Qiu and Zhang and colleagues call for further studies to verify the causal relationship between DII and testosterone deficiency. They also suggest that consuming a more anti-inflammatory diet “could be a feasible method to reduce the accumulated inflammatory burden, [potentially] leading to an increased testosterone level.”

Click here to read “The Association between Dietary Inflammatory Index and Sex Hormones among Men in the United States.”
DOI: 10.1097/JU.0000000000001703


Provided by Wolters Kluwer Health

Study Finds Oral Testosterone Therapy Undecanoate is Effective, With No Liver Toxicity (Medicine)

Safety profile consistent with non-oral testosterone replacement products

An industry-supported study of an oral testosterone replacement therapy (TRT), testosterone undecanoate (TU, Jatenzo) finds it is an effective, long-term treatment for men with low testosterone levels, with no evidence of liver toxicity. The findings are being presented virtually at ENDO 2021, the Endocrine Society’s annual meeting.

TST is currently available in multiple modes of administration, including implantable pellets, transdermal gels and intramuscular injections. “For many men with low testosterone levels, an oral option is preferred to avoid issues associated with other modes of administration, such as injection site pain or transference to partners and children,” said lead researcher Ronald S. Swerdloff, M.D., of the Lundquist Research Institute in Torrance, California. “Before TU was approved, the only orally approved TST in the United States was methyl-testosterone, which was known to be associated with significant chemical-driven liver damage.”

The U.S. Food and Drug Administration approved TU in March 2019, and the medication was made commercially available in February 2020.

Swerdloff conducted a safety and efficacy analysis following two years of TU oral capsule administration in men with low testosterone levels. There were two parts of the study. The first study included men ages 18 to 75 with low testosterone levels who were followed for 12 months. After the first year, 86 men enrolled in the second study, which lasted for another year.

Over two years, TU kept total testosterone levels in the normal range, with a safety profile relatively consistent with other approved testosterone products. There was no evidence of liver toxicity. There were small but statistically significant increases in prostate specific antigen (PSA), a protein produced by the prostate, and hematocrit (HCT), which measures red blood cell levels. Swerdloff noted these increases are observed with other forms of TST, regardless of modes of administration. The drug had minimal effects on LDL “bad” cholesterol, while lowering HDL “good” cholesterol, as is common with other TRT formulations.

“Our study finds TU is an effective oral therapy for men with low testosterone levels, and has a safety profile consistent with other approved testosterone products, without the drawbacks of non-oral modes of administration,” Swerdloff said.

Clarus Therapeutics supported the research.

###

Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the world’s oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

The Society has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site at www.endocrine.org. Follow us on Twitter at @TheEndoSociety and @EndoMedia.


Provided by Endocrine Society

For Men With Lower Levels During Puberty, Higher Testosterone Increases Brain Response to Faces (Neuroscience)

For men with lower levels during puberty, higher testosterone increases brain response to faces

Young men with lower testosterone levels throughout puberty become more sensitive to how the hormone influences the brain’s responses to faces in adulthood, according to new research published in JNeurosci.

During prenatal brain development, sex hormones like testosterone organize the brain in permanent ways. But research suggests that testosterone levels during another developmental period — puberty — may have long-lasting effects on brain function, too.

Liao et al. examined the relationship between puberty testosterone levels and the brain’s response to faces. Liao’s team recruited 500 men around age 19 who had been participants in the Avon Longitudinal Study of Parents and Children, a British birth cohort study established in 1991-1992. The longitudinal study collected blood samples at several time points throughout puberty, which the research team used to determine testosterone levels. The study participants were asked to watch videos of facial expressions while in in an fMRI scanner and provide a saliva sample on the day of the scan. For men with lowest testosterone levels during puberty, high levels of testosterone on the day of the fMRI scan were linked to greater brain activity in areas sensitive to faces. However, men with higher levels of testosterone throughout puberty did not show an increase in activity in these brain areas with high testosterone levels. These results highlight that an individual’s history, not just their state on a given day, may contribute to the individual differences often seen in brain responses.

Featured image: Changes in blood flow in brain regions when viewing angry and ambiguous facial expressions. Purple = low puberty testosterone, gray = medium, and green = high. © Liao et al., JNeurosci 2021


Reference: Zhijie Liao, Steven Tilley, Andrei Mouraviev, Ammar Khairullah, Tomas Paus and for the IMAGEN Consortium, “Pubertal testosterone and brain response to faces in young adulthood:An interplay between organizational and activational effects in young men”, Journal of Neuroscience 15 February 2021, JN-RM-0190-20; DOI: https://doi.org/10.1523/JNEUROSCI.0190-20.2021


Provided by Society for Neuroscience

Testosterone Nasal Spray to Treat Anxiety Disorders (Medicine)

A testosterone-containing nasal spray received its second U.S. patent and its first patent in Europe, making it the first testosterone therapy licensed to treat anxiety disorders.

Research has shown that although there is no difference in anxiety disorders among prepubescents, puberty introduces a sharp uptick in anxiety disorders in girls, who naturally have about one-tenth the amount of testosterone as boys. © University of Texas

Although testosterone therapy is most often marketed and prescribed to men suffering from “low T” — testosterone deficiency or hypogonadism — researchers with The University of Texas at Austin and MedCara Pharmaceuticals developed a nasal spray in response to a long-standing research question about why women are twice as likely as men to develop anxiety disorders.

“A growing body of research points to testosterone’s importance in the etiology of anxiety disorders,” said Robert Josephs, a professor of psychology at UT Austin who along with MedCara pharmacist Craig Herman developed the spray.

Research has shown that although there is no difference in anxiety disorders among prepubescents, puberty introduces a sharp uptick in anxiety disorders in girls, who naturally have about one-tenth the amount of testosterone as boys. The researchers speculated that men’s higher concentrations of circulating testosterone may protect against anxiety and began developing a treatment to address the issue.

“With this second U.S. patent and a first European patent supporting these claims, we’re one step closer to introducing a new weapon in the ongoing battle against mental illness,” said Josephs, who is also an adjunct professor of psychiatry in UT Austin’s Dell Medical School.

The first patent for his invention was issued in April 2019, with broad claims as a treatment option for fear-based disorders. This second U.S. patent, however, has the power to change the way testosterone therapy is used and how anxiety disorders are treated.

Although testosterone is not currently prescribed for anxiety, Josephs hopes that a short-term, fast-acting testosterone product might be prescribed alongside a lower dosage of benzodiazepines — such as Xanax or Klonopin — for treating anxiety disorders such as PTSD and OCD.

“Although benzodiazepines work well, they have strong sedative effects,” Josephs said. “Testosterone is not sedating.”

The aqueous-based nasal spray also addresses a current market need for comfortable, controlled, and fast-acting dosages of testosterone for people struggling with “low T” or a decreased libido. Traditional testosterone supplements, including drops, transdermal creams and gels, injections and subcutaneous “seeds,” can take days and/or multiple doses to reach full potential. Testosterone is in high demand, with prescriptions increasing fivefold since 2011.

The nasal spray (U.S. Patent No. 10,258,63, issued April 16, 2019; U.S. Patent No. 10,751,348, issued Aug. 25, 2020) has been licensed to Acerus Pharmaceuticals Corporation, which has the flexibility under the current agreement to use the technology in whatever medical field it deems most appropriate.

A Chinese patent is also forthcoming, paving the way for the psychology professor’s invention to be available worldwide.

Provided by University of Texas at Austin

Testosterone Can Prevent Type 2 Diabetes in Men (Medicine)

The largest investigation of testosterone treatment ever undertaken has shown that, over and above the effect of a lifestyle program, treatment with testosterone prevents or reverses newly diagnosed type 2 diabetes in men.

(© stock.adobe.com)

The study, known as T4DM (Testosterone for the prevention of Diabetes Mellitus), was led by the University of Adelaide and involved six specialist centers across Australia.

T4DM was a two-year randomized, double-blind, placebo-controlled clinical trial. The results are published online today in The Lancet Diabetes & Endocrinology.

The T4DM study included more than 1000 men aged between 50 and 74 years old who were overweight or obese. All men were enrolled in the WW (formerly known as Weight Watchers) lifestyle program. They could attend groups, use the website, the app, or any combination of those. Half of the men were injected with long-acting testosterone every three months and the other half were injected with placebo.

After two years of treatment, 87 out of 413 (21%) men in the placebo group had type 2 diabetes (based on an oral glucose tolerance test) compared with 55 out of 443 (12%) men in the testosterone group.

Men in both groups lost weight (on average 3 to 4kg) and glucose tolerance normalized in 43% and 52% of men in the placebo and testosterone groups, respectively.

Other findings at two years in men treated with testosterone compared to placebo:

* A lower fasting blood sugar
* A greater decrease in body fat
* An increase in skeletal muscle mass and hand grip strength
* Improvements in sexual function
* There were no differences in wellbeing or quality of life.
* The most common adverse effect occurring in 22% of men treated with testosterone was an increase in the concentration of red cells in the blood, which could potentially lead to “sludgy” blood.

Lead researcher Professor Gary Wittert, director of the Freemason’s Center for Male Health and Wellbeing, University of Adelaide, said: “The results of the study show that, on top of modest weight loss achieved with healthy eating and increased activity, testosterone has some added benefit to prevent or reverse newly diagnosed type 2 diabetes.

“However, the results do not necessarily mean that a script for testosterone should be written. We know that men at risk of type 2 diabetes are usually overweight and either have, or are at risk of, other chronic disorders that have not been detected or adequately managed. Not infrequently these men are also drinking too much alcohol and have sleep or mood disorders. Weight loss achieved through healthy lifestyle behaviors remains the benchmark.”

More research is needed to determine whether the beneficial effects of testosterone persist beyond two years, whether longer term treatment is safe and whether other forms of testosterone have similar benefits or risks.

“Writing a prescription might be quick and easy but it does not replace the need for undertaking a comprehensive assessment and providing holistic management towards improving men’s health,” Professor Wittert said.

Professor Bu Yeap from the University of Western Australia’s Medical School, and president of the Endocrine Society of Australia, who was an investigator on the study, said: “This is a landmark study which will prompt renewed interest in preventing diabetes in at-risk men.”

References: Gary Wittert, et al. Testosterone treatment to prevent or revert type 2 diabetes in men enrolled in a lifestyle programme (T4DM): a randomised, double-blind, placebo-controlled, 2-year, phase 3b trial. The Lancet Diabetes & Endocrinology 2020. doi.org/10.1016/S2213-8587(20)30367-3

Provided by University of Adelaide