To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Testosterone Gel Improves Insulin Sensitivity, Sexual Function in Hypogonadal Men With Diabetes and Metabolic Syndrome: Presented at ENDO 08 URL: http://www.pslgroup.com/dg/223F02.htm Doctor's Guide June 20, 2008
by Bryan DeBusk, PhD SAN FRANCISCO -- June 20, 2008 -- A topical, metered-dose, 2% testosterone gel improves both insulin sensitivity and sexual function in hypogonadal men with metabolic syndrome and/or type 2 diabetes, according to findings from a multicentre, randomised, double-blind, placebo-controlled trial. T. Hugh Jones, MD, Barnsley Hospital, University of Sheffield, Sheffield, United Kingdom, presented the results of the Testosterone Replacement in Hypogonadal Men With Either Metabolic Syndrome or Type 2 Diabetes (TIMES 2) study here on June 17 at the Endocrine Society's 90th Annual Meeting (ENDO 08). "Potentially, the prevalence of hypogonadism in men with type 2 diabetes approaches one-third," Dr. Jones explained. "Clearly this is a major potential health problem. "In a small number of patients we've shown that by giving testosterone back to these men, it's improved their insulin sensitivity, reducing insulin resistance, improving glycaemic control, cholesterol levels, and reduced waist circumference," Dr. Jones said. "What we wanted to do is look over a longer period." The study included 220 hypogonadal men, aged 37 to 88 years (mean, 60 years), with metabolic syndrome (80%) and/or type 2 diabetes (64%). Baseline fasting glucose, homeostasis model assessment-insulin resistance (HOMA-IR), and symptom profile were obtained for all patients. Patients were randomised to receive 2% testosterone gel 3 g (testosterone 60 mg) per day or placebo gel. Following 14 days of treatment, serum testosterone levels were obtained and participants received appropriate dose titration to achieve levels of >17 nmol/L. Among patients with type 2 diabetes with or without metabolic syndrome, insulin resistance as measured by HOMA-IR improved from baseline in the testosterone-treated group compared with placebo at 6 months (testosterone: -0.62, placebo: +0.16; P = .049) and at 12 months (testosterone: -.58, placebo: +0.33; P = .01). Of the patients with metabolic syndrome with or without type 2 diabetes, insulin resistance as measured by HOMA-IR also improved from baseline in the testosterone-treated group compared with placebo at 6 months (testosterone: -0.56, placebo: +0.12; P = .069) and at 12 months (testosterone: -0.41, placebo: +0.14; P = .054). Patients receiving testosterone also achieved more than a 5-point improvement over placebo-treated patients on the International Index of Erectile Function (IIEF) at 6 months (P < .05) and more than 6 points over placebo-treated patients at 12 months (P < .05). Overall, 102 patients (46%) completed the study with similar rates of attrition in both the testosterone- and placebo-treated groups. Although 66% of testosterone-treated participants and 59% of placebo-treated participants reported mild, moderate, or severe adverse events, only 17% of testosterone-treated participants and 11% of placebo-treated participants withdrew from the study as a result of the reported event. Only 19% of reported events were skin-related. "These improvements, if maintained in routine clinical practice, could potentially lead to an overall reduction in cardiovascular risk in the long term," Dr. Jones concluded. "And aside from all the comorbidity issues, by giving testosterone you can help these people with other quality-of-life issues." [Presentation title: A Placebo Controlled Study on the Effects of Transdermal Testosterone Gel in Hypogonadal Men With Type II Diabetes or Metabolic Syndrome in Diabetic Control and Insulin Sensitivity: The TIMES 2 Study. Abstract P3-422.] --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.