madman
Super Moderator
Background
Male Hypogonadism is common in Type 2 Diabetes with a prevalence of 40% having symptoms of testosterone deficiency [1]. Testosterone deficiency is associated with reduced Quality of Life (QOL), sexual, physical and psychological health.
Furthermore, testosterone deficiency is associated with increased Cardiovascular Risk caused by Insulin Resistance, poor Glycemic control, Dyslipidemia and Visceral Obesity.
Testosterone therapy has been shown to be an insulin sensitizor reducing resistance as well as in some studies decreasing HbA1c but not all {2].Testosterone therapy also increases muscle mass and decreases fat mass with very significant overall weight loss after 12 months.
Importantly patients with low testosterone have more than a two-fold increase in mortality compared to a diabetic man with normal testosterone status[3]. Testosterone replacement improves the survival to that compared that of a eugonadal diabetic patient. THE T4D a large placebo controlled RCT over 2 years reduced progression of men with prediabetes to overt diabetes by 50% [4].
The TRAVERSE study (n=5200) FDA required Cardiovascular Safety study showed that testosterone therapy did not increase MACE events [5]
Objective
To determine the symptomatic response to testosterone therapy in men with hypogonadism and type 2 diabetes. 2. To assess any effect on B=HbA1c, lipid profile, BMI, waist circumference, BP using data from tests routinely checked in routine clinical care.
Methods and Material
Clinical Centres treating men with Diabetes were recruited to input routine clinic data on patients assessed for Testosterone Deficiency.Patient identifying data was encrypted by each participating centre. Specific new and follow up audit forms online provided by ABCD. Data only included from routine clinical practise. Each centre can independently audit their own data.
Periodic data evaluated as aim is to eventually collect more patient inputs to be able to determine differences in response to several parameters. The current presentation gives interim data collected 196 evaluable patients for HbA1c, Weight, Waist circumference and AMS symptom and QoL score. (Fig 1)
Summary of Results
BASELINE DATA (n=196)
Mean Age 70.7+ 9.35 years
Weight 114.24 + 17.54 kg
Waist Circumference 104.8 + 16.8 cm
Testosterone 9.22 + 1.74 nmol/l
Aging Male Symptom Score (AMS) 40.83/85 Normal Range <30/85
Diabetes Medication Changes – Not yet assessed
Conclusions
1. Testosterone Replacement Therapy (TRT) for Diabetic Men with Hypogonadism improves Symptoms and Quality of Life in of testosterone deficiency. This benefit persist for at least 12 months.
2. TRT also has an add-on benefit in the control of glycemia, significantly lowering HbA1c over a 2-year follow up period.
3. At one-year there was effect on weight and waist circumference which is not unexpected as the increase in Muscle Mass cancels out the reduction in Fat Mass. This phenomenon has been shown in many RCT’s of TRT.
4. These are preliminary results from an ongoing audit which plans to collect data from over one thousand patients worldwide. This will enable us to identify which type of patients responds to TRT.
Male Hypogonadism is common in Type 2 Diabetes with a prevalence of 40% having symptoms of testosterone deficiency [1]. Testosterone deficiency is associated with reduced Quality of Life (QOL), sexual, physical and psychological health.
Furthermore, testosterone deficiency is associated with increased Cardiovascular Risk caused by Insulin Resistance, poor Glycemic control, Dyslipidemia and Visceral Obesity.
Testosterone therapy has been shown to be an insulin sensitizor reducing resistance as well as in some studies decreasing HbA1c but not all {2].Testosterone therapy also increases muscle mass and decreases fat mass with very significant overall weight loss after 12 months.
Importantly patients with low testosterone have more than a two-fold increase in mortality compared to a diabetic man with normal testosterone status[3]. Testosterone replacement improves the survival to that compared that of a eugonadal diabetic patient. THE T4D a large placebo controlled RCT over 2 years reduced progression of men with prediabetes to overt diabetes by 50% [4].
The TRAVERSE study (n=5200) FDA required Cardiovascular Safety study showed that testosterone therapy did not increase MACE events [5]
Objective
To determine the symptomatic response to testosterone therapy in men with hypogonadism and type 2 diabetes. 2. To assess any effect on B=HbA1c, lipid profile, BMI, waist circumference, BP using data from tests routinely checked in routine clinical care.
Methods and Material
Clinical Centres treating men with Diabetes were recruited to input routine clinic data on patients assessed for Testosterone Deficiency.Patient identifying data was encrypted by each participating centre. Specific new and follow up audit forms online provided by ABCD. Data only included from routine clinical practise. Each centre can independently audit their own data.
Periodic data evaluated as aim is to eventually collect more patient inputs to be able to determine differences in response to several parameters. The current presentation gives interim data collected 196 evaluable patients for HbA1c, Weight, Waist circumference and AMS symptom and QoL score. (Fig 1)
Summary of Results
BASELINE DATA (n=196)
Mean Age 70.7+ 9.35 years
Weight 114.24 + 17.54 kg
Waist Circumference 104.8 + 16.8 cm
Testosterone 9.22 + 1.74 nmol/l
Aging Male Symptom Score (AMS) 40.83/85 Normal Range <30/85
Diabetes Medication Changes – Not yet assessed
Conclusions
1. Testosterone Replacement Therapy (TRT) for Diabetic Men with Hypogonadism improves Symptoms and Quality of Life in of testosterone deficiency. This benefit persist for at least 12 months.
2. TRT also has an add-on benefit in the control of glycemia, significantly lowering HbA1c over a 2-year follow up period.
3. At one-year there was effect on weight and waist circumference which is not unexpected as the increase in Muscle Mass cancels out the reduction in Fat Mass. This phenomenon has been shown in many RCT’s of TRT.
4. These are preliminary results from an ongoing audit which plans to collect data from over one thousand patients worldwide. This will enable us to identify which type of patients responds to TRT.
