Information for patients

Categories

You can filter the research news achive by selecting one or multiple categories from the following list.















  Show all news

 

15 February 2015

Testosterone and Weight Loss - the Evidence

Testosterone and Weight Loss - the Evidence

Lowered testosterone in male obesity: mechanisms, morbidity and management. Ng Tang Fui M, Dupuis P, Grossmann M. Asian journal of andrology. 2014;16(2):223-231.

Testosterone and weight loss: the evidence. Traish AM. Current opinion in endocrinology, diabetes, and obesity. 2014;21(5):313-322.

Testosterone as potential effective therapy in treatment of obesity in men with testosterone deficiency: a review. Saad F, Aversa A, Isidori AM, Gooren LJ. Current diabetes reviews. 2012;8(2):131-143.

The role of testosterone in the etiology and treatment of obesity, the metabolic syndrome, and diabetes mellitus type 2. Saad F, Gooren LJ. Journal of obesity. 2011

It is well documented that obesity may cause hypogonadism, and that hypogonadism may cause obesity.1-4 This has generated debate about what condition comes first; obesity or hypogonadism? And what should be the first point of intervention?

In this editorial we summarize data from several reviews on the association of obesity and hypogonadism1-4, and make the case that obesity and hypogonadism create a self-perpetuating vicious circle. Once a vicious circle has been established, it doesn’t matter where one intervenes; one can either treat the obese condition or treat hypogonadism first. The critical issue is to break the vicious circle as soon as possible before irreversible health damage arises.

Nevertheless, as we will explain here, treating hypogonadism first may prove more effective in that it to a large extent “automatically” takes care of the excess body fat and metabolic derangements, and also confers psychological benefits that will help obese men become more physically active. Thereby, restoring testosterone levels in hypogonadal obese men will relatively quickly break the self-perpetuating vicious circle, and transform it into a “health promoting circle.”

Key Points

  • Non-obese men who become obese experience a decline of testosterone levels comparable to that of 10 years of aging.
  • Testosterone deficiency and obesity each contribute independently to a self-perpetuating vicious cycle. Long-term testosterone replacement therapy in men with hypogonadism improves body composition, metabolic syndrome components and quality of life, and thereby can help break the vicious cycle.
  • Treatment of hypogonadism with long-term testosterone replacement therapy, with or without lifestyle modifications, effectively treats obesity by correcting testosterone deficiency; one physiological root cause of obesity.
  • In contrast to the U-shaped curve for weight loss seen with traditional obesity treatments, which are characterized by weight loss and weight regain, treatment with testosterone replacement therapy results in a continuous reduction in obesity parameters (waist circumference, weight and BMI) for >5 years, or until metabolic abnormalities return to healthy ranges.
  • The significant effectiveness of testosterone replacement therapy in combating obesity in hypogonadal men remains largely unknown to doctors. Educational efforts are therefore critical to bring research findings into clinical practice in order to improve patient care and health outcomes.

15 February 2015

Testosterone and Weight Loss - the Evidence

Testosterone and Weight Loss - the Evidence

Lowered testosterone in male obesity: mechanisms, morbidity and management. Ng Tang Fui M, Dupuis P, Grossmann M. Asian journal of andrology. 2014;16(2):223-231.

Testosterone and weight loss: the evidence. Traish AM. Current opinion in endocrinology, diabetes, and obesity. 2014;21(5):313-322.

Testosterone as potential effective therapy in treatment of obesity in men with testosterone deficiency: a review. Saad F, Aversa A, Isidori AM, Gooren LJ. Current diabetes reviews. 2012;8(2):131-143.

The role of testosterone in the etiology and treatment of obesity, the metabolic syndrome, and diabetes mellitus type 2. Saad F, Gooren LJ. Journal of obesity. 2011;2011.

It is well documented that obesity may cause hypogonadism, and that hypogonadism may cause obesity. This has generated debate about what condition comes first; obesity or hypogonadism? And what should be the first point of intervention?

In this editorial we summarize data from several reviews on the association of obesity and hypogonadism, and make the case that obesity and hypogonadism create a self-perpetuating vicious circle. Once a vicious circle has been established, it doesn’t matter where one intervenes; one can either treat the obese condition or treat hypogonadism first. The critical issue is to break the vicious circle as soon as possible before irreversible health damage arises.

Nevertheless, as we will explain here, treating hypogonadism first may prove more effective in that it to a large extent “automatically” takes care of the excess body fat and metabolic derangements, and also confers psychological benefits that will help obese men become more physically active. Thereby, restoring testosterone levels in hypogonadal obese men will relatively quickly break the self-perpetuating vicious circle, and transform it into a “health promoting circle.”

5 September 2014

Effects of testosterone replacement therapy in men with hypogonadism

Alleged concerns regarding risk of cardiovascular disease with testosterone replacement therapy have been promulgated recently. However, a large and growing number of intervention studies show to the contrary that testosterone therapy reduces cardiovascular risk factors and confers multiple beneficial health effects. Thus, fears promoted by some recent flawed studies need to be critically re-evaluated.

This summary gives an overview of a comprehensive review of studies that have investigated health effects and safety of testosterone therapy. As outlined here, the position that hypogonadism (also known as testosterone deficiency) should be regarded as a risk factor for cardiovascular disease is supported by a rapidly expanding body of evidence.



Key Points

  • Testosterone therapy has beneficial effects on body composition:

    • Increased muscle mass
    • Reduced visceral fat mass
    • Reduced total body fat mass
  • Testosterone therapy has beneficial effects on lipid profile:

    • Reduced Total cholesterol (TC)
    • Reduced LDL cholesterol
    • Reduced triglycerides (TGs)
    • Increased HDL levels
  • Testosterone therapy has beneficial effects on cardiovascular function:

    • Reduced arterial stiffness
    • Reduced CIMT (carotid intima media thickness)
    • Reduced blood pressure
  • Testosterone therapy has beneficial effects on glucose metabolism, which reduce risk of diabetes:

    • Increased insulin sensitivity
    • Reduced glucose levels
    • Reduced HbA1c levels
  • Testosterone therapy has beneficial effects on inflammatory parameters:

    • Decreased levels of liver enzymes
    • Decreased CRP levels
    • Reduction in inflammatory cytokines
  • Testosterone therapy has beneficial effects on longevity:

    • Reduced risk of mortality and improved survival
  • Testosterone therapy has beneficial effects on sexual function:

    • Increased libido, improved erectile function and ejaculatory function
  • Testosterone therapy has beneficial effects on quality of life:

    • Less fatigue and improvement in energy, mood, vitality
  • This review in addition highlights results from multiple long-term registry studies which demonstrate the following key results:

    • Testosterone therapy effectively restores physiological testosterone levels within the first 12 months and these restored testosterone levels are maintained with testosterone therapy throughout the entire study period, which at this point is up to 6 years.
    • Long-term testosterone therapy results in a marked and sustained reduction in body weight and waist circumference (figure 1), BMI, CRP, HbA1c and improves the lipid profile by reducing total cholesterol, LDL and triglycerides while increasing HDL.
    • It is especially notable that the long-term reductions in body weight, waist circumference and HbA1c keep progressing throughout 5 years, and further improve after each year of testosterone therapy.
  • Safety of TRT

    • The most common side effects of testosterone therapy are increases in hematocrit and PSA. However, these elevations occur within the first 12 months, and thereafter remain stable with continued testosterone therapy for up to 5 years. This corroborates findings from a previous 3 year-long study which demonstrated that elevations (within the reference range) of hemacocrit and PSA plateau at 12 months and 6 months respectively, after initiation of testosterone therapy.
    • 5 years of testosterone therapy also does not change the International Prostate Symptom Score (IPSS), maximum urinary flow (Qmax) rate, post-void residual (PVR) volume, or prostate size.Thus, long-term testosterone therapy does not impact negatively on lower urinary tract symptoms (LUTS) and prostate volume.

5 September 2014

Long-term testosterone therapy is associated with a reduction in obesity parameters, improved metabolic syndrome and health-related quality of life in men with hypogonadism

Testosterone therapy in hypogonadal men results in sustained and clinically meaningful weight loss. Yassin AA, Doros G. Clinical Obesity 2013;3:73–83.

Long-term testosterone treatment in elderly men with hypogonadism and erectile dysfunction reduces obesity parameters and improves metabolic syndrome and health-related quality of life. Yassin DJ, Doros G, Hammerer PG, et al. J Sex Med 2014;11:1567–76.

This editorial summarises two papers based on the same observational study of 261 hypogonadal men: the first focused specifically on obesity and assessed the long-term effects of normalising testosterone (T) levels on obesity parameters. The second paper focused on parameters associated with the metabolic syndrome (MetS) as well as obesity measures.

Hypogonadism is associated with several clinical symptoms, including increased adiposity, reduced muscle mass, reduced bone density, obesity, diabetes, and erectile dysfunction (ED). Diabetes and obesity are of particular concern as they are well known risk factors for cardiovascular disorders. Although, several studies have found that treatment with T can ameliorate these symptoms, it is not known if these improvements can be sustained in the long-term. The studies summarised in this editorial investigated the long-term effects of testosterone undecanoate (TU) on a number of these symptoms.

Both papers analysed the same registry of 261 hypogonadal men (aged 59.5 ± 8.4 years), all of whom had sought treatment for ED at a single urologist’s office. Patients received parenteral TU 1000 mg at baseline, week 6 and every 12 weeks thereafter for up to 5 years. All 261 patients were followed for ≥1 year, 260 patients for 2 years, 237 for 3 years, 195 for 4 years and 163 for 5 years. Adherence to treatment was excellent and the decline in patient numbers each year represented duration of treatment rather than drop-out rates.

The first paper measured anthropometric parameters. Patient height, body weight, body mass index (BMI) and waist circumference (WC) were measured at baseline, and weight, BMI and WC were measured at least once a year. Blood samples were taken prior to the next TU injection, consequently this meant that T levels measured were trough levels.

The second paper also measured (at baseline and at every visit) body weight, WC and BMI as well as parameters associated with the MetS; total cholesterol, LDL, HDL, triglycerides, glucose, HbA1c (glycated hemoglobin), blood pressure (BP) and total T concentrations.



Key Points

  • In an unselected cohort of hypogonadal men presenting with ED to a single urologist’s office, only 4% were of normal weight, 34% were overweight, and 62% were obese

    • Only 3% had a normal WC (≤94 cm), 28% had an increased waist size (94–101.9 cm), and 69% had a substantially increased waist size (≥102 cm)
  • At the end of the observation period (maximum 5 years) 96% of men had lost weight (mean loss 11.1 kg)

    • 98% of men showed a reduction in WC with a mean decrease of 9.4 cm
  • In the obese subgroup (n=162), mean weight loss was 12.8 kg and mean reduction in WC was 10.5 cm
  • MetS parameters were measured in the same overall cohort:

    • Lipid pattern improved with substantial and sustained reductions in total cholesterol, LDL and triglycerides, and an increase in HDL
    • The total cholesterol to HDL ratio, a cardiovascular risk marker, declined from 6.84 to 4.09 over the course of the study
    • Fasting glucose and HbA1c decreased suggesting improved glycemic control
    • Both systolic and diastolic BP decreased significantly
  • Long-term health-related quality of life was improved by TU treatment resulting from contributions of sustained improvements in erectile function (p<0.0001) and muscle and joint pain
  • No increased risk of prostate cancer was observed; prostate cancer was seen in only 2.3% of TU treated hypogonadal men

5 September 2014

Effects of testosterone replacement therapy in men with hypogonadism

Alleged concerns regarding risk of cardiovascular disease with testosterone replacement therapy have been promulgated recently. However, a large and growing number of intervention studies (where medication was used) show to the contrary that testosterone therapy reduces cardiovascular risk factors (diseases of the heart and blood vessels) and confers multiple beneficial health effects. Thus, fears promoted by some recent flawed studies need to be critically re-evaluated.

This summary gives an overview of a comprehensive review of studies that have investigated health effects and safety of testosterone therapy. As outlined here, the position that hypogonadism (also known as testosterone deficiency) should be regarded as a risk factor for cardiovascular disease is supported by a rapidly expanding body of evidence.

6 May 2014

Testosterone replacement therapy and its withdrawal in hypogonadal men with severe obesity

Big guy sweating on the bike

Effects of testosterone undecanoate replacement and withdrawal on cardio-metabolic, hormonal and body composition outcomes in severely obese hypogonadal men: a pilot study. Francomano D, Bruzziches R, Barbaro G, et al. J Endocrinol Invest 2014; [Epub ahead of print]

Obesity is a chronic, worldwide health problem that has serious economic and social consequences. This summary discusses the results of an observational, open-label, parallel-arm study that investigated the cardiometabolic effects of diet and physical exercise (DPE) with or without testosterone undecanoate (TU) 1,000 mg/12 weeks for 54 weeks in 24 hypogonadal men with severe obesity (mean age, 54 ± 8 years; total testosterone level, <12 nmol/L; mean BMI, 42 kg/m2). A 24-week extension period of DPE alone investigated the effects of withdrawal of TU from treatment. The DPE program consisted of a personalized hypocaloric diet and requirement to complete ≥150 min/week of aerobic exercise of moderate intensity and/or ≥90 min/week of vigorous exercise.



Key Points

  • Testosterone undecanoate (TU) + diet and physical exercise (DPE) improved hormonal and cardiometabolic parameters at 54 weeks in hypogonadal men with severe obesity, but improvements were not maintained following withdrawal of TU for 24 weeks
  • This is the second study to demonstrate the added benefit of testosterone treatment to DPE
  • This is the second study to show that testosterone + DPE resulted in significant and persistent improvements in body composition, weight loss, and reductions in all metabolic syndrome parameters at 54 weeks

    • Lean mass (p<0.0001) and fat mass (p<0.01) were improved only in the DPE + TU group, but were lost after withdrawal of TU for lean mass only
    • DPE + TU improved glycemia, basal and peak insulin serum levels, total and LDL cholesterol, and both systolic and diastolic blood pressure, and significance was maintained after withdrawal of TU (all p<0.01)
  • Epicardial fat, a measure of cardiovascular performance, was significantly reduced in the DPE + TU group (p<0.01) but not in the group without TU treatment; however, improvements were not maintained following withdrawal of TU
  • This is the first study to show that DPE + TU improved surrogate markers of endothelial function, measured using the Endopat2000 device; however, such improvements were lost following TU withdrawal

    • Significant improvements in T/B ratio and CIMT were achieved only in the DPE + TU group (both p<0.01) at 54 weeks
    • Only patients treated with DPE + TU showed a significant reduction of overall cardiovascular risk (p<0.01)

7 March 2014

Testosterone treatment in obese hypogonadal men with type 2 diabetes

Testosterone treatment in obese hypogonadal men with type 2 diabetes

Effects of long-term testosterone therapy on patients with “diabesity”: Results of observational studies of pooled analyses in obese hypogonadal men with type 2 diabetes. Haider A, Yassin A, Doros G, et al. Int J Endocrinol 2014; [Epub ahead of print]

Obesity is a chronic disease of increasing concern in developing and developed countries. It is associated with many comorbidities, including insulin resistance, type 2 diabetes mellitus (T2DM), and hypogonadism (testosterone deficiency [TD]). Patients who present with obesity and T2DM, termed “diabesity”, have an increased risk of cardiovascular disease (CVD). This summary discusses the key findings from a report using pooled data from two long-term, observational, prospective, cumulative registry studies to investigate the use of parenteral testosterone undecanoate (TU) 1,000 mg in obese hypogonadal men with T2DM.



Key Points

  • Treatment with testosterone undecanoate (TU) 1,000 mg was followed for up to 6 years, the longest follow-up period to date.
  • In total, 156 obese (BMI ≥30 kg/m2) hypogonadal men with T2DM and dyslipidemia, aged between 41–73 years, were investigated
  • TU significantly and progressively improved anthropometric parameters of obesity over 6 years

    • Waist circumference (p<0.0001), actual body weight (p=0.001), percentage body weight change (p<0.0001), and BMI (p<0.0001) were improved over 6 years compared with baseline and each year compared to previous year
  • TU progressively and significantly decreased levels of HbA1c by a mean of 1.93 ± 0.06% over 6 years (p<0.0001) and each year compared to previous year
  • Measures of BP, lipid profiles, liver enzymes, and levels of inflammatory biomarkers were significantly improved after 6 years

    • Mean improvements in systolic (23.15 ± 0.83 mmHg) and diastolic (15.07 ± 0.8 mmHg) BP reached a level of statistical significance (p<0.0001) at 3 years, and were sustained for 6 years
    • Improvements in HDL-C (+35.03 ± 5.11%), total cholesterol (–32.12 ± 1.41%), LDL-C (–25.93 ± 1.63%), triglycerides (–29.91 ± 2%), liver enzymes aspartate transaminase (12.01 ± 1.33 U/L) and alanine transaminase (12.46 ± 1.83 U/L), and the inflammatory marker C-reactive protein (2.88 ± 0.28 U/L) were gradual and significant (all p<0.0001)
Last updated: 2018
L.ZA.MKT.GM.10.2016.1381