Association Between Type 2 Diabetes and Hypogonadism in India: An Observational Study.

Introduction: Hypogonadism is a common comorbidity associated with several metabolic disorders including type 2 diabetes (T2D) that can remain undetected without proper screening. Here, we evaluated the prevalence of hypogonadism in Indian male patients with T2D with or without obesity.

Methods: In this prospective, observational study, male patients with T2D and hypogonadism were evaluated symptomatically using the androgen deficiency in ageing male (ADAM) questionnaire at baseline and confirmed on the basis of total testosterone (TT) levels (<300 ng/dL) at Days 5-7 (Visit 2) and 9-14 (Visit 4) assessed after 12 hours of fasting between 8 AM and 10 AM. Prevalence of hypogonadism was presented as proportion of patients.

Results: Of 598 enrolled patients, 526 completed the study. Mean (standard deviation [SD]) age was 50.4 (9.12) years. The percentage of patients with TT <300 ng/dL at visit 2 was 18.4%, while upon repeat confirmation, it reduced to 8.6%. Thus, the prevalence of true hypogonadism was 8.6%. Prevalence of hypogonadism in patients with BMI range of >30 kg/m² (obese) was 11.1%. At screening, 81.4% (487 of 598) patients had positive ADAM questionnaire results.

Conclusions: Prevalence of hypogonadism in Indian patients with T2D was found to be 8.6% upon repeat evaluation of testosterone. Symptomatic (ADAM questionnaire) as well as biochemical (total testosterone levels with repeat evaluation) confirmation is vital in the definite diagnosis of male hypogonadism.