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Objective: This study evaluated the effects of testosterone replacement therapy (TRT) on insulin resistance, cardiovascular risk factors, and symptoms in hypogonadal men with type 2 diabetes and/or metabolic syndrome (MetS).Research Design and Methods: The efficacy, safety, and tolerability of a novel transdermal 2% testosterone gel was evaluated over 12 months in 220 hypogonadal men with type 2 diabetes and/or MetS in a multicenter, prospective, randomized, double-blind, placebo-controlled study. The primary outcome was mean change from baseline in homeostasis model assessment of insulin resistance (HOMA-IR). Secondary outcomes were measures of body composition, glycemic control, lipids, and sexual function. Efficacy results focused primarily on months 0-6 (phase 1; no changes in medication allowed). Medication changes were allowed in phase 2 (months 6-12).Results: TRT reduced HOMA-IR in the overall population by 15.2% at 6 months (P = 0.018) and 16.4% at 12 months (P = 0.006). In type 2 diabetic patients, glycemic control was significantly better in the TRT group than the placebo group at month 9 (HbA(1c): treatment difference, -0.446%; P = 0.035). Improvements in total and LDL cholesterol, lipoprotein a (Lpa), body composition, libido, and sexual function occurred in selected patient groups. There were no significant differences between groups in the frequencies of adverse events (AEs) or serious AEs. The majority of AEs (>95%) were mild or moderate.Conclusions: Over a 6-month period, transdermal TRT was associated with beneficial effects on insulin resistance, total and LDL-cholesterol, Lpa, and sexual health in hypogonadal men with type 2 diabetes and/or MetS. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The aim of our study was to assess the prevalence of clinical hypogonadism, based on both symptoms and biochemical available measures of testosterone deficiency, in men with type 2 diabetes. RESEARCH DESIGN AND METHODS: In a cross-sectional study of 355 type 2 diabetic men aged >30 years, total and bioavailable testosterone, sex hormone-binding globulin, BMI, and waist circumference were measured and free testosterone was calculated. Overt hypogonadism was defined as the presence of clinical symptoms of hypogonadism and low testosterone level (total testosterone <8 nmol/l and/or bioavailable testosterone <2.5 nmol/l). Borderline hypogonadism was defined as the presence of symptoms and total testosterone of 8-12 nmol/l or bioavailable testosterone of 2.5-4 nmol/l. RESULTS: A low blood testosterone level was common in diabetic men, and a significant proportion of these men had symptoms of hypogonadism. Overt hypogonadism was seen in 17% of men with total testosterone <8 nmol/l and 14% with bioavailable testosterone <2.5 nmol/l. Borderline hypogonadism was found in 25% of men with total testosterone 8-12 nmol/l and bioavailable testosterone between 2.5 and 4 nmol/l; 42% of the men had free testosterone <0.255 nmol/l. BMI and waist circumference were both significantly negatively correlated with testosterone levels in men, with the association being stronger for waist circumference. CONCLUSIONS: Testosterone levels are frequently low in men with type 2 diabetes, and the majority of these men have symptoms of hypogonadism. Obesity is associated with low testosterone levels in diabetic men. [ABSTRACT FROM AUTHOR]

OBJECTIVES: To compare a new low-dose warfarin induction regimen with the Fennerty regimen in elderly inpatients. DESIGN: Age-stratified, randomized prospective study. SUBJECTS: 120 age-stratified elderly inpatients. INTERVENTIONS: Each patient was randomized to either the new induction regimen or to a modified Fennerty regimen. MAIN OUTCOMES MEASURES: Days to therapeutic International Normalized Ratio (INR >2); days in the therapeutic range (INR 2-3) during induction; number of patients with INR >4.5; ability of day 4 INR to predict day 8 warfarin dose. RESULTS: The mean time to therapeutic INR was longer for the new induction regimen than modified Fennerty regimen in patients aged 65-75 years [4.6 (mean) +/- 1.6 (SD) days vs 3.8 +/- 0.8 days; P = 0.03] and in patients aged >75 years (4.5 +/- 1.4 days vs 3.5 +/- 0.7 days; P = 0.003). Patients spent more time in the therapeutic INR range with the new induction regimen [3.0 +/- 1.3 days vs 2.7 +/- 1.3 days (P = 0.03) for those aged 65-75 years and 2.9 +/- 1.1 days vs 2.4 +/- 1.3 days (P = 0.04 for those aged >75 years]. Fewer patients using the new regimen had INRs >4.5 in the first 8 days [1 (3%) vs 6 (20%) for 65-75 years (P < 0.05) and 1 (3%) vs 11 (37%) for >75 years (P < 0.01)]. The ability to predict the maintenance dose to within 1 mg was 55% for both regimens. CONCLUSION: The low-dose regimen has important clinical advantages over the Fennerty regimen for anticoagulating elderly inpatients. [ABSTRACT FROM AUTHOR]