1. The Prevalence of Male Hypotestosteronism in Type 2 Diabetics in a Southwest Virginia Population Dr. Eric Hofmeister Dr. Christopher Bishop

2. Background  Several studies have demonstrated a high prevalence of hypotestosteronism in males with T2DM.  The Hypotestosteronism in Males (HIM) study reported the prevalence of hypogonadism in males with T2DM to be 50%

3. The HIM Study  2162 eligible men > 45 years visiting primary care practices in the United States  Serum testosterone assessment by a single morning blood draw  Hypogonadism defined as total testosterone level < 300 ng/dL with one or more symptoms  Prevalence of hypogonadism in males with T2DM was 50%

4. Hypothesis  The prevalence of male hypotestosteronism within our local Southwest Virginia population is greater than 50%

5. Objective  Determine the Prevalence of hypotestosteronism in males with type II diabetes mellitus (T2DM) within a local population in Southwest Virginia.

6. Design  Non-randomized retrospective analysis  13 months  Data Analysis of all type 2 diabetic males that had received a total testosterone assessment

7. Methods  Solstas Lab Database  All patients that had received a total testosterone level assessment over a 13 month period  Utilized a T2DM inclusion / exclusion criteria to determine sample population

8. Methods  T2DM males assessed for the presence of hypotestosteronism by chart review (Allscripts Database) of a documented total serum testosterone level of less than 300 ng/dL  Excluded if no documentation of prior serum total testosteronism < 300 ng/dL  Determined percentage of T2DM males with a total testosterone level < 300 ng/dL

9. Inclusion / Exclusion Criteria  Male of any age  Type II Diabetes  A1C > 6.5 or fasting blood glucose > 126 mg/dL  Exclude  No documented A1C or fasting blood glucose level documentation, Hx of Type I Diabetes, chronic steroid use, or Hx of hypopituitarism

10. Sample Analysis 59 patients with measured testosterone + T2DM 97 patients with measured testosterone + documented A1c or glucose > 125 224 male patients with ≥ 1 serum testosterone 127 excluded (no gluc/A1c) 38 excluded (DM1, steroids..)

11. Results  41/59 (69.5%) have low T with T2DM  18/59 (31.5%) have normal T with T2DM 4

12. Demographics 144Mean serum glucose 7.9Mean A1c 207Mean testosterone 33.6Mean BMI 54.5Mean patient age

13. Concomitant Conditions 37 % (15/41)Tobacco smoking 37 % (15/41)CVD/CAD/MI 41 % (17/41)Insulin therapy 73 % (30/41)Oral hypoglycemics 32 % (13/41)Hypothyroidism 39 % (16/41)Opioid use

14. Discussion  Prevalence of T2DM in US high (26 million) and increasing –Increasing incidence of hypotestosteronism ?  No current recommendations regarding screening for low testosterone in males  Low testosterone associated with insulin resistance and T2DM independent of age, race, BMI 4

15. Discussion  Testosterone supplementation therapy shown in multiple studies to improve: –insulin resistance/utilization –Hemoglobin A1c –serum glucose –DBP –Total, HDL, & LDL cholesterol –increase lean body mass, decrease fat mass, waist circumference 4

16. Low Testosterone & Cardiovascular Disease  Multiple, conflicting studies… the good:  Several studies show an inverse relationship between cardiovascular disease and testosterone level –T2DM patients with high-normal testosterone have lower risk (25%) of acute MI vs lowest 25% 4

17. Low Testosterone & Cardiovascular Disease  Multiple, conflicting studies… the bad:  Some studies report an increased risk of non- fatal MI in middle-age and elderly patients with pre-existing heart disease given testosterone replacement –National Institute for Aging study –Veterans’ studies (JAMA, NEJM): 26% vs 20% risk of veterans for MI, stroke, and/or death 4

18. Testosterone Therapy Risks  Increased PSA.. worsening BPH  Hematopoiesis  hyperviscocity  Gynecomastia  Worsening male breast CA ?  OSA/insomnia  Decreased spermatogenesis  Increased or decreased heart disease? 4

19. Testosterone Therapy and Prostate Cancer  No evidence between exogenous testosterone and increase incidence or progression of prostate CA  Current evidence based largely on Huggins & Hodges study (1941). Several studies since 1941 have refuted that evidence… however ??? 4

20. Final Discussion  Higher prevalence of hypotestosteronism in SWVA T2DM patients vs. nationally?  Should we screen?  Should we recommend therapy? 4