RF34 | PMON263 Study of Testosterone Replacement in Hypogonadal Men With Uncontrolled Type 2 Diabetes – a Randomised Double Blinded Placebo Controlled Trial (STRIDE Study)
Authors: Mohan Rao Preethi , Mumdzic Enis , Kelly Daniel M , Hugh Jones T 
Published: November 2022

Objective

This RCT set out to test the effect of testosterone on glycaemic control, parameters of metabolic control and quality of life(QoL) in a cohort of people with poorly-controlled 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 type 2 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. Anthropometric measurements, questionnaires and biochemical parameters were recorded at baseline and every three months for a year.

Results

Mean age of the cohort was 59±8.98 years(mean±SD). Mean duration since diagnosis of diabetes was 8.6 years. 17(26%) were on insulin. Baseline cohorts were comparable. There was no improvement in mean HbA1c or fasting plasma glucose(FBG) between the active and placebo groups after 6 months of TRT. No difference was found in HbA1c or FBG at 12 months compared to baseline in the active group either.

Our study also showed a significant decrease in serum triglycerides (-0.497±0.213mmol/l, p=0.023) and improvement in left hand grip strength (p=0.025) at 6 months post treatment in the active group compared to placebo group. There was no significant difference in the mean weight, BMI, WC, WHR, fat mass, fat percentage or fat free mass between the groups.

Our study is the first ever RCT to show a significant improvement in total AMS (aging male symptom) scores from baseline after 6 months of TU treatment compared to placebo group (p&lt;0.05) in a cohort with poorly-controlled type 2 diabetes and hypogonadism. Another key finding from our study substantiating the clinical argument of treatment of patients with hypogonadism in diabetes cohort is that the proportion of patients with severe symptoms moving to a less severe category (low/mild/moderate severity) was 46% in the active vs only 28% in placebo group(p=0.0024).

Conclusions

Our study concludes that testosterone therapy did not have a significant improvement in glycaemic control at 6 months between the active and placebo groups and at 12 months within the in the active group and may need longer duration to see the positive effects especially in cohort of people who have had long duration of diabetes. There was a significant reduction in triglyceride levels and increase muscular strength after 6 months of TRT.

STRIDE study is the first ever RCT to show a significant improvement in clinical symptoms and symptom severity following testosterone treatment in patients with hypogonadism and type 2 diabetes after 6 months of testosterone treatment.

Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m., Monday, June 13, 2022 12:42 p.m. - 12:47 p.m.