low testosterone predicts mortality

Association of British Clinical Diabetologists

Testosterone & Diabetes Worldwide Audit

 
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Above: There is a very high prevalence of hypogonadism in men with Type 2 Diabetes. Causes of hypogonadism include many classical (e.g. Klinefelter’s Syndrome) as well as the more common functional aetiologies. Sexual dysfunction is the primary consequence of testosterone deficiency which can be distressing and severely affect quality of life - click to enlarge

 
Effect of testosterone replacement therapy on sexual function in T2DM

Above: Sexual dysfunction associated with testosterone deficiency has been shown to benefit from testosterone replacement in men with type 2 diabetes. Evidence also shows that men with failure of PDE5 inhibitor treatment are more likely to be testosterone deplete and over 50% can on testosterone therapy be converted to PDE-5 inhibitor responders – click to enlarge

 
Percentage mean change in HOMA-IR

Above: The majority of RCT’s have reported that testosterone replacement reduces insulin resistance in type 2 diabetes. Effects on HbA1c have been either positive or no effect. There is no definitive answer as there has been no large RCT performed  – click to enlarge

 
Long term follow up after testosterone replacement therapy

Above: A long-term registry study has followed men with type 2 diabetes and hypogonadism treated with testosterone and compared with a control group who declined therapy. This study has found beneficial effects of testosterone mainly becoming significant after 12 months on weight, BMI and waist circumference, fasting glucose, HbA1c, lipid profile and mortality – click to enlarge

 
low testosterone predicts mortality
Several epidemiological studies have reported that low testosterone is associated with a hazard ratio of greater than 2 for increased all-cause mortality. Testosterone treated hypogonadal men have improved survival and return to an average life expectancy for a testosterone replete man with type 2 diabetes - click to enlarge
 
HYPOGONADAL-OBESITY-ADIPOCYTOKINE HYPOTHESIS

Above:  – the hypogonadal-obesity-adipocytokine hypothesis - click to enlarge

 

ABCD worldwide audit of testosterone deficiency in men with type 2 diabetes

ABCD nationwide audit of testosterone deficiency in men with type 2 diabetes
There is a high prevalence (~40%) of Testosterone Deficiency in men with Type 2 Diabetes. Testosterone Deficiency is now recognised as a common co-morbid condition associated with type 2 diabetes. The ADA Standards of Medical Care in Diabetes 2021 (Recommendation 4.11) states that ‘In men with diabetes who have symptoms or signs of hypogonadism such as decreased sexual desire (libido) or activity, or erectile dysfunction, consider screening with a morning serum testosterone level’. Male hypogonadism is defined as a clinical syndrome which must include symptoms with or without signs and biochemical evidence of testosterone deficiency. National and International Guidelines are available which provide an evidence based to the management of testosterone deficiency in men. The management of hypogonadism requires a careful diagnosis and replacement of testosterone if indicated back to a consistently normal circulating testosterone level at least in the mid-normal healthy range.

The primary indication for testosterone therapy in men with diagnosed hypogonadism is sexual dysfunction. Clinical trials have demonstrated that symptoms of sexual function can improve with testosterone replacement therapy. Studies also suggest that there may be benefits on physical and psychological function as well. Clinical trials have reported that testosterone therapy reduces insulin resistance, body weight, waist circumference and some publications suggest there is an improvement in HbA1c, lipid profile, reduction in hepatic fat. A recent registry study has been published which demonstrates a gradual improvement in these parameters over several years with some patients entering remission of their diabetes. Epidemiological studies have found that testosterone deficiency is associated with a greater than two-fold increase in all-cause and cardiovascular mortality in men with type 2 diabetes as well as other populations. Reports also suggest that testosterone replacement in type 2 diabetes has a beneficial effect on survival. A recent large 2-year study has reported that testosterone therapy with pre-diabetes and low testosterone reduces the proportion of men developing type 2 diabetes over and above lifestyle changes.

Purpose of Audit
This audit sets out to help individual clinicians and to determine from several centres the clinical effects and monitoring of testosterone replacement therapy in men with type 2 diabetes and hypogonadism in real world clinical practise in the short and longer-term. Data can also be collected from men with hypogonadism where the decision by the patient or clinician is not to treat.
Monitoring is essential to be sure there is a clinical improvement, adequate replacement and to detect any adverse events. The haematocrit and PSA should be assessed at baseline, 3,6 and 12 months and yearly thereafter. Secondary polycythaemia can be managed in the majority of cases (see guidelines). There is no evidence that testosterone replacement causes the development of a new prostate carcinoma but may after initiation unmask a mall unidentified occult cancer a few months after initiation of treatment.  The audit has a number of objectives.

Collect data on-line or via paper forms
The Testosterone and Diabetes on-line audit tool is so easy to use that live data entry in clinic is a real option to be considered. Otherwise to facilitate data collection during clinics there are two paper forms which exactly match the data that can be entered into the audit tool. You can download and print these forms locally.

To download the forms to printout for use, use the following links:

Download first visit data entry form
Download follow up visit data entry form

Non ABCD members
Non ABCD members are welcome to take part in the audit and will be given access to the on-line audit tool when they register for the audit.

Analyse your own data
The tool will allow you to analyse the data of your own patients for your own local interest; at the same time the data will automatically be available for national analysis of anonymised data. Some videos showing ways of analysing your own data are available through the ABCD YouTube channel and some useful links to the videos can be found here.

Acknowledgement of contributors
As we have done with previous audits all contributors will be acknowledged in all papers and presentations from the audit data and biggest contributors will be offered the possibility of being co-authors.

Register to take part in the audit and access to the on-line tool
To register for the audit and be given access to the on-line tool on the ABCD website click here.

Further information
Further enquiries may be made to the ABCD nationwide audits database administrator of the project,
Melissa Cull

 

Register for the Testosterone & Diabetes audit

Access the on-line tool

Audit objectives

Rationale for Audit Form

Helpful clinical tips and suggestions

Links to clinical guidelines on management of testosterone deficiency

AMS questionnaire

AMS evaluation form

Download first visit data entry form

Download follow up visit data entry form

Further information- contact us

Main ABCD homepage

The ABCD worldwide Testosterone & Diabetes Audit is an independent audit supported by an unrestricted grant from Besins Healthcare

Working to support high quality diabetes care in the UK