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Sponsored by: |
Barnsley Hospital |
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Information provided by: | Barnsley Hospital |
ClinicalTrials.gov Identifier: | NCT00504712 |
There is increasing evidence of the linkage of type 2 diabetes with low testosterone levels in men. Testosterone treatment has shown beneficial effects on blood sugar control and obesity in pilot studies in men with type 2 diabetes. Beneficial effects have also been seen on angina- a disease related to atherosclerosis (narrowing of the arterial blood vessels). Peripheral vascular disease is also caused by atherosclerosis. We hypothesise that testosterone will have beneficial effects on peripheral vascualr disease in men with low serum testosterone and type 2 diabetes.
Condition | Intervention | Phase |
---|---|---|
Hypogonadism Peripheral Vascular Disease Type 2 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 Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus |
Estimated Enrollment: | 30 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2008 |
Arms | Assigned Interventions |
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ACTIVE: Experimental
Testosterone 200 mg intramuscular every 2 weeks
|
Drug: Testosterone
Sustanon- 200mg- Intramuscular testosterone every 2 weeks
|
PLACEBO: Placebo Comparator |
Drug: 0.9% saline
Saline injection every two weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Peripheral vascular disease as defined by
Exclusion Criteria:
Contact: Roger D Stanworth | 01226 777947 | roger.stanworth@nhs.net |
United Kingdom, South Yorkshire | |
Barnsley Hospital NHS Foundation Trust | Recruiting |
Barnsley, South Yorkshire, United Kingdom, S75 2EP | |
Contact: Roger D Stanworth 01226 777947 roger.stanworth@nhs.net |
Principal Investigator: | T Hugh Jones | Barnsley Hospital |
Study ID Numbers: | 300 |
Study First Received: | July 19, 2007 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00504712 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Testosterone Hypogonadism Diabetes PVD RCT |
Peripheral Vascular Diseases Metabolic Diseases Antineoplastic Agents, Hormonal Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases Diabetes Mellitus Endocrine System Diseases Methyltestosterone |
Hormones Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Androgens |
Peripheral Vascular Diseases Metabolic Diseases Antineoplastic Agents, Hormonal Antineoplastic Agents Gonadal Disorders Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Diabetes Mellitus Vascular Diseases Endocrine System Diseases Methyltestosterone |
Hormones Pharmacologic Actions Testosterone 17 beta-cypionate Anabolic Agents Testosterone Hypogonadism Therapeutic Uses Diabetes Mellitus, Type 2 Cardiovascular Diseases Glucose Metabolism Disorders Androgens |