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CompletedNCT00355537Updated Mar 30, 2010

Testosterone Replacement in Diabetes With Vascular Disease (Version 2)

A Phase 4 interventional study of Testosterone and 0.9% saline in Diabetes Mellitus and Peripheral Vascular Disease, sponsored by Barnsley Hospital. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-03-30.

Sponsored by Barnsley Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study 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,

02

Conditions studied

  • Diabetes Mellitus
  • Peripheral Vascular Disease
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 19 is below the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Barnsley Hospital is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    Active

    Drug: Testosterone

  • Placebo comparator
    Placebo

    Drug: 0.9% saline

Interventions

  • DrugTestosterone

    Sustanon- intramuscular testosterone 200mg every 2 weeks

  • Drug0.9% saline

    Saline injection intramuscular every 2 weeks

06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Barnsley Hospital NHS Foundation Trust
    Barnsley, South Yorkshire S75 2 EP, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2006, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2006
First posted
Jul 24, 2006
Start
Feb 2006
Primary completionActual
Dec 2009
CompletionActual
Dec 2009
Last update
Mar 30, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 30, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00355537
Lead sponsor
Barnsley Hospital
First posted
Jul 24, 2006
Start date
Feb 2006
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Mar 30, 2010

Study contacts

Hugh Jones
principal investigator · Barnsley Hospital NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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