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Sponsored by: |
Barnsley Hospital |
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Information provided by: | Barnsley Hospital |
ClinicalTrials.gov Identifier: | NCT00349362 |
The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.
Condition | Intervention | Phase |
---|---|---|
Hypogonadism Diabetes |
Drug: Testosterone Drug: 0.9% saline |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomised Double Blind Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin |
Estimated Enrollment: | 40 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | April 2008 |
Arms | Assigned Interventions |
---|---|
ACTIVE: Experimental |
Drug: Testosterone
Sustanon- 200mg intramuscular testosterone
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PLACEBO: Placebo Comparator |
Drug: 0.9% saline
Saline intramuscular injection every two weeks
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There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. Artificially induced hypogonadism results in increasing arterial stiffness whilst testosterone is known to improve risk factors for vascular disease and act as a vasodilator. The purpose of this pilot study is to test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hugh Jones, BSc MD FRCP | 01226 777947 ext 2212 | Hugh.Jones@nhs.net |
Contact: Roger Stanworth | 01226 730000 ext 2212 | Roger.Stanworth@nhs.net |
United Kingdom, South Yorkshire | |
Barnsley Hospital NHS Foundation Trust | Recruiting |
Barnsley, South Yorkshire, United Kingdom, S75 2EP |
Principal Investigator: | Hugh Jones, BSc MD FRCP | Barnsley Hospital NHS Foundation Trust |
Study ID Numbers: | BDGH 264 |
Study First Received: | July 6, 2006 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00349362 |
Health Authority: | United Kingdom: National Health Service |
Metabolic Diseases Gonadal Disorders Diabetes Mellitus Endocrine System Diseases Methyltestosterone Insulin Testosterone 17 beta-cypionate |
Testosterone Hypogonadism Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |
Anabolic Agents Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs |
Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions Androgens |