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Sponsored by: |
Austin Health |
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Information provided by: | Austin Health |
ClinicalTrials.gov Identifier: | NCT00613782 |
In men with type 2 diabetes, low testosterone levels have been associated with insulin resistance, truncal obesity and symptoms such as fatigue and erectile dysfunction. Low testosterone may impair cardiac function and increase cardiovascular risk and cause osteoporosis. The goal of this project is to assess prospectively whether, in men with type 2 diabetes mellitus and low testosterone levels, testosterone replacement improves insulin resistance, body composition, bone density, cardiac function symptoms associated with low testosterone level.
We will recruit 140 ambulatory men with type 2 diabetes and a low serum testosterone level (<10 nmol/L) from Austin Health Endocrine clinics, General Practise surgeries, and from the general public by direct consumer advertising via newspaper and other local media. Men will be randomised to either intramuscular testosterone undecanoate (Reandron 1000, Bayer Schering Pharma) or placebo. Men with contraindications to testosterone replacement or to intramuscular injections will be excluded from the study. All men will receive intramuscular testosterone or placebo injections at 0, 6, 18 and 30 weeks (a total of four injections).
All 140 study subjects will have a clinical and laboratory assessment at baseline, 18 weeks and at study end (40 weeks). All 140 subjects will also have imaging studies at baseline and at study end (40 weeks). The study protocol is outlined in more detail below:
Clinical and laboratory assessment (Baseline and repeated 18 weeks, 40 weeks) A full medical history and physical examination will be performed. Symptoms will be assessed by the following standardised questionnaires: 1) Androgen Deficiency in the Aging Male (ADAM); 2) Aging Male Symptom scale (AMS); 3) International Index of Erectile Dysfunction (IIED); 4) International Prostate Symptom Score (IPSS); 5) SF-36 (all five questionnaires are attached to Module 1).
Laboratory studies will consist of blood tests to measure total testosterone, fasting glucose, C-peptide, HBA1c and other routine parameters.
Imaging studies (Baseline and repeated at 40 weeks)
Condition | Intervention | Phase |
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Type 2 Diabetes Hypogonadism |
Drug: Reandron 1000 Drug: placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment |
Official Title: | Testosterone Replacement Therapy in Men With Type 2 Diabetes Mellitus and Low Testosterone Levels |
Estimated Enrollment: | 140 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Reandron 100 treatment
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Drug: Reandron 1000
1000mg at 0,6,18,30 weeks
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2: Placebo Comparator
Placebo
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Drug: placebo
placebo injection 0,6.18.30 weeks
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mathis Grossmann | 61394965477 | mathisg@unimelb.edu.au |
Contact: Jeffrey D Zajac | 61394965477 | j.zajac@unimelb.edu.au |
Australia, Victoria | |
Austin Health | |
Heidelberg, Victoria, Australia, 3084 |
Principal Investigator: | Mathis Grossmann | Austin Health |
Responsible Party: | Austin Health ( Dr. Mathis Grossmann or Professor Jeffrey D. Zajac ) |
Study ID Numbers: | Reandron 1000 (ZK 5488) 321399 |
Study First Received: | January 31, 2008 |
Last Updated: | February 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00613782 |
Health Authority: | Australia: Human Research Ethics Committee |
Testosterone Metabolic Diseases Hypogonadism Gonadal Disorders Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Methyltestosterone Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Testosterone 17 beta-cypionate |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |