Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

This study has been completed.
Sponsor:
Information provided by:
Barnsley Hospital
ClinicalTrials.gov Identifier:
NCT00355537
First received: July 21, 2006
Last updated: March 29, 2010
Last verified: March 2010

July 21, 2006
March 29, 2010
February 2006
December 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00355537 on ClinicalTrials.gov Archive Site
  • The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound . [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) . [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound .
  • 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.
  • The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) .
  • 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.
Not Provided
Not Provided
 
Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
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

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,

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Peripheral Vascular Disease
  • Drug: Testosterone
    Sustanon- intramuscular testosterone 200mg every 2 weeks
  • Drug: 0.9% saline
    Saline injection intramuscular every 2 weeks
  • Experimental: Active
    Intervention: Drug: Testosterone
  • Placebo Comparator: Placebo
    Intervention: Drug: 0.9% saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00355537
BDGH 237
No
Prof Hugh Jones, Barnsley Hospital
Barnsley Hospital
Not Provided
Principal Investigator: Hugh Jones Barnsley Hospital NHS Foundation Trust
Barnsley Hospital
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP