HypogonadismPhase 4NCT00349362
Testosterone for Men With Insulin Treated Type 2 Diabetes
A Phase 4 study testing Testosterone and 0.9% saline in people with Hypogonadism and Diabetes, run by Barnsley Hospital at 1 site in United Kingdom.
Trial summary
The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypogonadism, Diabetes
- 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
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2006to Oct 2008
- 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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- males over 40 years old
- type 2 diabetes treated with insulin
- serum testosterone less than 12nmol/L on 2 consecutive morning samples
- symptoms attributable to hypogonadism
Who cannot join
- current or previous breast cancer
- current or previous prostate cancer
- raised prostate specific antigen or abdominal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy
- severe symptoms of benign prostatic hypertrophy
- treatment with testosterone in the three months prior to the trial
- investigational drug treatment in the three 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 2EP
About this study
Official title: A Randomised Double Blind Placebo Controlled, Parallel Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin
The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.
Read the detailed description
There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. 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 test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.
- Conditions
- Hypogonadism, Diabetes
- Being tested
- Testosterone, 0.9% saline
- Medical subject headings
- Hypogonadism, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Sustanon- 200mg intramuscular testosterone
0.9% salineDrug
Saline intramuscular injection every two weeks
| Study group | Role | What they receive |
|---|---|---|
| Testosterone | Experimental | Testosterone injections- 200mg- every 2 weeks Receives: Drug: Testosterone |
| Placebo | Placebo comparator | Normal saline injections- every two weeks 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 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin.
Measured: 6 months
Secondary outcomes (5)
The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population
Measured: 6 months
The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS)
Measured: 6 months
The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,
Measured: 6 months
urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population.
Measured: 6 months
The effect of the CAG repeat polymorphism in exon 1 of the androgen receptor gene on the response of the study population to testosterone.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies 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
- Double blind
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barnsley Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hugh Jones, BSc MD FRCP, Principal investigator, Barnsley Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00349362
- Sponsor's protocol ID
- BDGH 264
- Status last verified
- Mar 2010
- First submitted
- 6 Jul 2006
- Last updated
- 30 Mar 2010
- Results posted
- 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 Pilot Study to Test the Effect of Testosterone Replacement on Glycaemic Control and Arterial Wall Properties of Hypogonadal Men With Type 2 Diabetes Treated With Insulin
- ClinicalTrials.gov ID
- NCT00349362
- Acronym / sponsor ID
- BDGH 264
- Conditions
- Hypogonadism, Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Barnsley HospitalUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 7 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.
The purpose of this study is to test the effect of testosterone treatment on glycaemic control, arterial stiffness and IMT in hypogonadal men with type 2 diabetes treated with insulin.
Detailed description
There is epidemiological data linking low serum testosterone levels in men with the development of diabetes. Clinical trials have indicated a potential benefit of testosterone treatment in improving diabetic control and insulin resistance. Type 2 diabetes is also associated with changes in arterial stiffness and IMT which are known to be linked to the presence of cardiovascular disease. 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 test the effect of six months of testosterone replacement, given as testosterone esters 200mg from Sustanon 250 IM injection, on diabetes control in hypogonadal men with type 2 diabetes treated with insulin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone | Experimental | Drug: TestosteroneTestosterone injections- 200mg- every 2 weeks |
| Placebo | Placebo comparator | Drug: 0.9% salineNormal saline injections- every two weeks |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- males over 40 years old
- type 2 diabetes treated with insulin
- serum testosterone less than 12nmol/L on 2 consecutive morning samples
- symptoms attributable to hypogonadism
Key exclusion criteria (6 listed)
- current or previous breast cancer
- current or previous prostate cancer
- raised prostate specific antigen or abdominal digital rectal examination suspicious of prostate cancer unless diagnosis excluded after specialist urology opinion and/or prostate biopsy
- severe symptoms of benign prostatic hypertrophy
- treatment with testosterone in the three 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- 200mg intramuscular testosterone | Drug | Testosterone |
| 0.9% salineSaline intramuscular injection every two weeks | Drug | Placebo |
Primary outcome
The effect of 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin.
Time frame: 6 months
5 secondary outcomes
The effect of testosterone on ultrasound measured intima-media thickness of the common carotid artery in the study population
Time frame: 6 months
The effect of testosterone on male hypogonadism as assessed by the Ageing Males Symptoms (AMS)
Time frame: 6 months
The effect of testosterone on markers of vascular risk; blood pressure, serum lipid levels, weight, waist circumference, body fat percentage,
Time frame: 6 months
urinary micro-albumin, tumour necrosis factor alpha, and highly sensitive C reactive protein levels in the study population.
Time frame: 6 months
The effect of the CAG repeat polymorphism in exon 1 of the androgen receptor gene on the response of the study population to testosterone.
Time frame: 6 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, BSc MD FRCP 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 Hypogonadism and Diabetes, 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 4 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 6 months of testosterone replacement on diabetes control measured by HbA1c in hypogonadal men with type 2 diabetes treated with insulin. (time frame: 6 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.