MON-654 - No Significant Relationship between Baseline Serum Testosterone and Body Composition Changes Observed in Older Men Receiving Incretin-Mimetic Therapy for Type 2 Diabetes

Background: Incretin-mimetic therapy (IT) in patients with type 2 diabetes (T2D) can result in considerable weight loss and glycemic improvement. Body composition analyses suggest that approximately a third of this weight loss incurred is lean mass. Men with T2D are at risk for low serum testosterone (T) concentrations and hypogonadism, which may predispose to loss of lean mass and gain of fat mass. We hypothesized that men with lower baseline serum T will have greater lean mass loss and less fat mass loss than those with normal T concentrations.

Methods: We performed an observational, prospective, pilot study of men ≥ 40 years age, with T2D starting IT. Anthropometrics, serum T and body composition using dual energy X-ray absorptiometry (DXA) were measured at baseline and after 6 and 12 months of therapy. Wilcoxon matched-pairs signed rank test was used to compare the change in outcome measures over time. Correlation of T with outcome measures was tested using Spearman’s method.

Results: Twenty-four men were enrolled in the study and 22 of them have completed 6-month follow up, as of this writing. All 24 men have remained on their IT without drop-out. Preliminary data from 22 men who completed the 6-month follow up visit showed: median (Q1, Q3) baseline age 61 (57, 60) years, body mass index 32 (29, 36) kg/m2, hemoglobin A1C 7.2 (6.6, 7.8) %, serum total T 268 (223, 294) ng/dL, and calculated free T 59 (51, 67) pg/mL. Free T was below the lower limit of normal (LLN) in 3/22 (14%) participants, while total T was low in 10/22 (46%). Over 6 months of IT, median weight loss was 4.8 kg (1.8, 5.9; p < 0.001). Median change in lean mass was -0.54 kg (-0.5, 2; p=0.06) and change in fat mass was -3 kg (-1.2, -4.9; p< 0.001). Waist circumference reduced by a median of 3.1 cm (1.3, 6.4; p< 0.001) and hip circumference reduced by a median of 3.1 cm (0.6, 4.9; p< 0.001). None of the changes in anthropometrics, weight and body composition correlated with baseline total or free T. When body composition changes were analyzed by quartiles of serum total or free T, no significant differences between the groups were found. Comparison of body composition changes between participants with serum free T or total T below LLN and those with normal values also did not show significant differences.

Conclusions: Older men with T2D receiving 6 months of IT experienced significant reductions in weight, waist and hip circumference, and fat mass. Lean mass was not significantly reduced. Contrary to our hypothesis, baseline total and free T concentrations did not correlate with changes in weight, body composition or anthropometrics in men with T2D after 6 months of IT. These preliminary data do not suggest the need for T supplementation in this population of men to prevent loss of lean mass during IT.

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