NCT00355537

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,

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_4 diabetes-mellitus

Timeline
Completed

Started Feb 2006

Longer than P75 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 24, 2006

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 30, 2010

Status Verified

March 1, 2010

Enrollment Period

3.8 years

First QC Date

July 21, 2006

Last Update Submit

March 29, 2010

Conditions

Diabetes MellitusPeripheral Vascular Disease

Outcome Measures

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.

    3 months

Secondary Outcomes (4)

  • The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound .

    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.

    3 months

  • The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) .

    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.

    3 months

Study Arms (2)

Active

EXPERIMENTAL
Drug: Testosterone

Placebo

PLACEBO COMPARATOR
Drug: 0.9% saline

Interventions

TestosteroneDRUG

Sustanon- intramuscular testosterone 200mg every 2 weeks

Active
0.9% salineDRUG

Saline injection intramuscular every 2 weeks

Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnsley Hospital NHS Foundation Trust

Barnsley, South Yorkshire, S75 2 EP, United Kingdom

Location

MeSH Terms

Conditions

Diabetes MellitusPeripheral Vascular Diseases

Interventions

TestosteroneSaline Solution

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Hugh Jones

    Barnsley Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 24, 2006

Study Start

February 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 30, 2010

Record last verified: 2010-03

Locations

GB(1)