Diabetes MellitusPhase 4NCT00355537
Testosterone Replacement in Diabetes With Vascular Disease (Version 2)
A Phase 4 study testing Testosterone and 0.9% saline in people with Diabetes Mellitus and Peripheral Vascular Disease, run by Barnsley Hospital at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diabetes Mellitus, Peripheral Vascular Disease
- What is being tested?
- Testosterone and 0.9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2006to Dec 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barnsley Hospital NHS Foundation Trust
Barnsley, South Yorkshire, S75 2 EP
About this study
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
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,
- Conditions
- Diabetes Mellitus, Peripheral Vascular Disease
- Being tested
- Testosterone, 0.9% saline
- Medical subject headings
- Diabetes Mellitus, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Sustanon- intramuscular testosterone 200mg every 2 weeks
0.9% salineDrug
Saline injection intramuscular every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: Testosterone |
| Placebo | Placebo comparator | Not described Receives: Drug: 0.9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (4)
The effect of testosterone on intima-media thickness of the femoral artery measured by ultrasound .
Measured: 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.
Measured: 3 months
The effect of testosterone on PVD as measured by ankle-brachial-pressure-indices (ABPI) .
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2006 (estimated)
- Study startFeb 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barnsley Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hugh Jones, Principal investigator, Barnsley Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355537
- Sponsor's protocol ID
- BDGH 237
- Status last verified
- Mar 2010
- First submitted
- 21 Jul 2006
- Last updated
- 30 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00355537
- Acronym / sponsor ID
- BDGH 237
- Conditions
- Diabetes Mellitus, Peripheral Vascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Barnsley HospitalUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: Testosterone |
| Placebo | Placebo comparator | Drug: 0.9% saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TestosteroneSustanon- intramuscular testosterone 200mg every 2 weeks | Drug | Active |
| 0.9% salineSaline injection intramuscular every 2 weeks | Drug | Placebo |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hugh Jones principal investigator
Barnsley Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone and 0.9% saline in people with Diabetes Mellitus and Peripheral Vascular Disease, run by Barnsley Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2010.