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Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00355537
Recruitment Status : Completed
First Posted : July 24, 2006
Last Update Posted : March 30, 2010
Information provided by:
Barnsley Hospital

Brief Summary:
Diabetes is a major cause of peripheral vascular disease(PVD) and is associated with male hypogonadism. Diabetes and PVD are both associated with arterial stiffness and intima -media thickness which are also related to severity of the clinical syndrome of PVD. 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 assess the effect of testosterone treatment on PVD arterial stiffness and intima-media thickness in men with type 2 diabetes and hypogonadism,

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Peripheral Vascular Disease Drug: Testosterone Drug: 0.9% saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo-controlled Parallel Study to Test the Effect of Testosterone Treatment on Peripheral Vascular Disease in Hypogonadal Men With Type 2 Diabetes Mellitus
Study Start Date : February 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Drug: Testosterone
Sustanon- intramuscular testosterone 200mg every 2 weeks

Placebo Comparator: Placebo Drug: 0.9% saline
Saline injection intramuscular every 2 weeks

Primary Outcome Measures :
  1. The effect of testosterone replacement on arterial stiffness measured by ultrasound derived index B of the femoral artery in men with a combination of DM, PVD and hypogonadism. [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound . [ Time Frame: 3 months ]
  2. The effect of testosterone on peripheral circulation in legs affected by PVD as measured by transcutaneous oxygen saturation in the feet of the study population. [ Time Frame: 3 months ]
  3. The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) . [ Time Frame: 3 months ]
  4. The effect of testosterone on markers of vascular risk; blood pressure, serum-lipid levels, weight, waist circumference, body fat percentage, urinary micro-albumin concentration and C reactive protein levels. [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male patients greater than 18 years of age
  • Type 2 Diabetes Mellitus
  • Serum testosterone less than 11 nmol/L on two consecutive samples taken on different days
  • Peripheral vascular disease as defined by ABPI less than 0.92 and ischaemic leg pain (claudication or rest pain) or distal complications (non-healing arterial foot ulcer or gangrene
  • Agreement to maintain antihypertensive and anti-lipid treatments at prior doses during 3 months of study
  • Ability to give written informed consent after verbal and written explanation in the English Language
  • Ability to comply with all study requirements

Exclusion Criteria:

  • Current or previous breast cancer
  • Current or previous prostate cancer
  • Raised prostate specific antigen or abnormal per rectal examination unless prostate cancer excluded after specialist urology opinion
  • Severe symptoms of benign prostatic hypertrophy ('prostatism')
  • Treatment with testosterone in the 3 months prior to the trial
  • Investigational drug treatment in the 3 months prior to the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00355537

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United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom, S75 2 EP
Sponsors and Collaborators
Barnsley Hospital
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Principal Investigator: Hugh Jones Barnsley Hospital NHS Foundation Trust
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Responsible Party: Prof Hugh Jones, Barnsley Hospital Identifier: NCT00355537    
Other Study ID Numbers: BDGH 237
First Posted: July 24, 2006    Key Record Dates
Last Update Posted: March 30, 2010
Last Verified: March 2010
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs