Testosterone therapy improves quality of life in men with hypogonadism, type 2 diabetes
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ATLANTA — Testosterone undecanoate therapy is associated with improved quality of life and reduced symptom severity in men with hypogonadism and type 2 diabetes, according to data presented at ENDO 2022.
“Testosterone replacement therapy in men with type 2 diabetes with testosterone deficiency improved quality of life as assessed by the Aging Males’ Symptom (AMS) score,” Hugh Jones, MBChB, MD, FRCP, consultant endocrinologist at Barnsley Hospital and the University of Sheffield in the U.K., and president of the Androgen Society, told Healio. “This is the first randomized controlled trial to demonstrate this benefit. After 12 months of therapy, there are more marked benefits in quality of life, including sexual, physical and psychological health, and early evidence that memory can improve.”
Jones and colleagues conducted a randomized, double-blind, placebo-controlled trial in which 65 men aged 18 years or older with type 2 diabetes, an HbA1c between 7% and 9.5%, and confirmed hypogonadism were randomly assigned to testosterone undecanoate (Nebido, Bayer AG) or placebo for 6 months. At 6 months, the trial entered an open-label phase in which placebo participants shifted to the treatment group. The AMS questionnaire, SF-36, International Index of Erectile Function, Mini-Mental State Examination, Barnsley Diabetes Hypogonadism Questionnaire and the New England Research Institutes (NERI) hypogonadism screener were conducted to measure quality of life outcomes at baseline and every 3 months.
At 6 months, the testosterone group had a reduction in AMS score from 48.34 at baseline to 37.72, whereas the placebo group had a smaller reduction from 48.34 to 42.78 (P < .05). The percentage of participants reporting less severe symptoms was higher in the treatment group compared with placebo (46% vs. 28%; P = .0024). There were no significant differences in other questionnaire scores.
At 12 months, there were significant improvements in AMS score and all subscales compared with baseline. Additionally, participants had significant improvements in libido as well as reductions in total Barnsley Diabetes Hypogonadism Questionnaire score and in the sexual well-being (P = .002) and emotional well-being domains (P = .011). Improvements in the physical health domain and health change of the SF-36 were observed at 12 months (P = .019 for both). Improvements in the delayed verbal recall domain of the Mini-Mental State Examination were observed at 3, 6, 9 and 12 months (P = .0004).
“Men with type 2 diabetes and symptoms of testosterone deficiency should be checked with blood testosterone measurement,” Jones said. “If a diagnosis of testosterone deficiency is confirmed, these men should be offered testosterone replacement therapy to normalize their testosterone status. The ADA already recommended in their Standards of Care from 2018 that low testosterone is associated with type 2 diabetes in men, and symptomatic men should be investigated for testosterone deficiency.”
Jones said more studies are needed with larger study cohorts and as well as to examine the values of testosterone therapy for men with type 2 diabetes and early dementia.
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