PMON265 First Ever Placebo-Controlled Randomised Study of Testosterone on Ambulatory Blood Pressure and Heart Rate in Hypogonadal Men With Uncontrolled Type 2 Diabetes – STRIDE Study
Authors: Mohan Rao Preethi , Durani Mohammad , Jones Thomas Hugh 
Published: November 2022

Background

Testosterone has been historically believed to increase blood pressure(BP) and hence bad for heart despite no convincing evidence to prove this. Self-administered use of anabolic steroids has adverse cardiac effects including hypertension. Many RCTs that have looked at the effect of TRT have been BP measurements using mercury sphygmomanometer. Our study is the first RCT looking at the effect of testosterone on ambulatory BP in patients with type 2 diabetes and hypogonadism.

Research design and methods: This is a randomised double blinded placebo-controlled add-on trial of intramuscular testosterone undecanoate (Nebido®) administered every 12 weeks in 65 hypogonadal men with poorly-controlled diabetes. Phase 1 patients were randomly assigned to either treatment or placebo arm for 6 months of TRT. Phase 2 was an open-labelled phase for 6 months and patients on placebo moved on to the treatment group wherein patients in the treatment group continued. Diurnal Ambulatory-BP measurements were performed with Spacelabs 90217 mounted on the non-dominant upper arm over 24-hours.

Results

Mean age of the cohort was 59(42-77)years. 55.4% of the patients had hypertension at baseline. Baseline characteristics were comparable between active/placebo groups apart from cardiovascular disease and hypertension which were significantly higher in the active group compared to placebo group (n=28 vs n=18, p=0.05), (n=23 vs n=13, p=0.008) respectively.

There was no significant difference in 24-hours ambulatory average SBP or DBP before and after TRT for 6 months (SBP p=0.407, DBP p=0.649). There were no significant changes in average daytime or night-time SBP (p=0.291), (p=0.295) respectively or average daytime DBP (p=0.566) or night-time DBP (p=0.879) either. There was no significant difference in the total average heart rate and day time average heart rate however night time average heart rate showed a significant reduction of around 4 beats/minute (p=0.046) between the two groups at 6 months. There was no significant difference in the values for the above parameters in the normotensive group (average baseline ambulatory BP≤ 140/90 mm of Hg) and hypertensive group (≥ to 140/90 mm of Hg) either. There was no change in antihypertensive medications in the first 6 months.

Mean 24-hour ambulatory BP components were compared at 0, 3, 6, 9 and 12 months for participants in the active group before and after treatment with testosterone undecanoate. There was no significant change in the total, day or night-time systolic or diastolic BP levels before and after the treatment.

Conclusions

Our study concludes that testosterone given as a replacement hormone in hypogonadal patients with type 2 diabetes does not increase 24-hour ambulatory systolic or diastolic BP. Our study also shows that testosterone causes a decrease in average night-time heart rate of 4 to 5 beats/minute and the cause and significance of such a decrease needs further detailed evaluation.

Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.