Testosterone replacement therapy improved sexual symptoms, libido, symptom severity, delayed verbal recall and overall quality of life among people with poorly controlled type 2 diabetes and hypogonadism, according to research being presented Monday at ENDO 2022, the Endocrine Society’s annual meeting in Atlanta, Ga.
This is the first randomized controlled trial to show significant improvements from testosterone replacement therapy, according to lead author, Preethi Mohan Rao, M.B.B.S., M.R.C.P., C.C.S.T., M.D., and Prof. Hugh Jones, consultants in diabetes and endocrinology at the Barnsley Hospital NHS Foundation Trust in Barnsley, U.K., and University of Sheffield in Sheffield, U.K.
“The findings are welcome news to men with diabetes and hypogonadism, since they often have a poor quality of life,” Rao said.
Rao and colleagues conducted a randomized, double-blind, placebo-controlled add-on trial of intramuscular testosterone undecanoate (Nebido®, TRT) administered every 12 weeks in 65 men (mean age 59 years) with poorly-controlled diabetes and hypogonadism. In Phase 1, patients were randomly assigned to either treatment or placebo for 6 months of TRT. Phase 2 consisted of an open-label format for 6 months and those administered placebos were moved into the treatment group. Patients in the treatment group continued treatment.
In Phase 1, the mean total Aging Male Symptoms (AMS) score, which is a quality of life assessment tool in men, significantly decreased from a baseline of 48.34±13.13 to 37.72±12.25 at 6 months after TRT compared with placebo (p<0.05). Those who were administered TRT were more likely to move on from severe symptoms to low, mild, or moderate symptoms compared to those in the placebo group (46% vs. 28%, p=0.0024). However, there were no significant findings from SF-36 scores, MMSE scores, BDHQ, NERI or IIEF-5 scores or its domains at baseline and after 6 months of TRT.
In Phase 2, the AMS total score (p=001) and all its subscales (physical p=0.01), psychological (p=0.026), and sexual (p<0.001), with improvement in libido (p<0.001) showed significant improvements. Sexual wellbeing (p=0.002) and emotional wellbeing (p=0.011) were also significantly improved (p=0.07). In addition, QoL scores revealed better physical health (p=0.019) and health change (p=0.019). Statistically significant changes were noted for delayed verbal recall (an early sign of dementia) in this phase, as well (p=0.0004).
“These findings will also form the evidence basis for our general practitioners and endocrinologists to proactively ask their diabetes patients about the symptoms at their regular health visits and investigate and diagnose hypogonadism appropriately and treat them with testosterone where indicated,” Rao said. “Our trial showed that the treatment is very safe when accurately monitored.”
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Journal of the Endocrine Society