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Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

This study has been completed.
Information provided by:
Barnsley Hospital Identifier:
First received: July 21, 2006
Last updated: March 29, 2010
Last verified: March 2010
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 Intervention Phase
Diabetes Mellitus Peripheral Vascular Disease Drug: Testosterone Drug: 0.9% saline Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Barnsley Hospital:

Primary Outcome Measures:
  • 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:
  • The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound . [ Time Frame: 3 months ]
  • 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 ]
  • The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) . [ Time Frame: 3 months ]
  • 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 ]

Enrollment: 19
Study Start Date: February 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: Testosterone
Sustanon- intramuscular testosterone 200mg every 2 weeks
Placebo Comparator: Placebo Drug: 0.9% saline
Saline injection intramuscular every 2 weeks


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00355537

United Kingdom
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, United Kingdom, S75 2 EP
Sponsors and Collaborators
Barnsley Hospital
Principal Investigator: Hugh Jones Barnsley Hospital NHS Foundation Trust
  More Information

Responsible Party: Prof Hugh Jones, Barnsley Hospital Identifier: NCT00355537     History of Changes
Other Study ID Numbers: BDGH 237
Study First Received: July 21, 2006
Last Updated: March 29, 2010

Additional relevant MeSH terms:
Diabetes Mellitus
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents processed this record on September 25, 2017