Metabolic SyndromePhase 2MVENTNCT01077479
Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
A Phase 2 study testing Metformin in people with Metabolic Syndrome and Hypercholesterolemia, run by Western Sydney Local Health District at 1 site in Australia.
Trial summary
The main purpose of this study is to assess the efficacy of metformin in abrogating androgen deprivation therapy (ADT) induced insulin resistance as measured by homeostasis model assessment (HOMAIR) in men with non-metastatic prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metabolic Syndrome, Hypercholesterolemia
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2010to Jun 2013
- Phase
- Phase 2
- 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
- ≥ 18 years of age
- ECOG ≤ 1
- Histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only (≤ 5 sites of bone metastases only)
- Plan to receive ≥ 6 months continuous androgen deprivation therapy by a GnRH agonist
- Patients who are to receive antiandrogens with GnRH agonists are not excluded from the study. But the form, dose and duration of antiandrogen treatment should be recorded.
- Adequate renal function (Creatinine ≤ 177mMol/L and GFR >30 mls/min )
- Adequate hepatic function (Bilirubin must be ≤ 1.5 x upper limit of normal range, ALT and ALP must be ≤ 2.5 x upper limit of normal)
Who cannot join
- Visceral involvement
- > 5 sites of bone metastases
- History of confirmed diabetes mellitus (patients with impaired fasting glucose or impaired glucose intolerance will not be excluded) 12
- Treatment with medications that may alter glucose or insulin level within 3 months (including insulin, oral hypoglycemic agents, systemic corticosteroid of any dosage, atypical antipsychotic drugs of any dose)
- Malignant disease other than prostate cancer at the time of enrolment
- Bilateral orchiectomy
Show all 11Show fewer
- Previous androgen deprivation therapy by a GnRH agonist or anti-androgen within last 12 months(patient who had a GnRH agonist more than 12 months ago are allowed if their testosterone levels are in the normal range at the time of recruitment)
- Chemotherapy within 6 months
- History of lactic acidosis
- Cardiac or respiratory insufficiency, severe infection that is likely to increase the risk of lactic acidosis
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The main purpose of this study is to assess the efficacy of metformin in abrogating androgen deprivation therapy (ADT) induced insulin resistance as measured by homeostasis model assessment (HOMAIR) in men with non-metastatic prostate cancer.
- Conditions
- Metabolic Syndrome, Hypercholesterolemia
- Being tested
- Metformin
- Keywords
- body fat mass gain, Insulin resistance
- Medical subject headings
- Metabolic Syndrome, Hypercholesterolemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Metformin 1500mg nocte for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Not described Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks
Measured: 12 and 24 weeks
Secondary outcomes (5)
To assess the efficacy of metformin in abrogating ADT-induced insulin resistance as measured by whole-body insulin sensitivity index(ISI) at 3 and 6 months
Measured: 12 and 24 weeks
To assess the efficacy of metformin in reducing the incidence of ADT-induced metabolic syndrome at 3 and 6 months
Measured: 12 and 24 weeks
To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months
Measured: 24 weeks
To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months
Measured: 12 and 24 weeks
To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Gurney, Western Sydney Local Health District
- Investigators
- Howard Gurney, MBBS, FRACP, Principal investigator, Westmead Cancer Care Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077479
- Sponsor's protocol ID
- HGWH009
- Acronym
- MVENT
- Status last verified
- May 2014
- First submitted
- 26 Feb 2010
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT01077479
- Acronym / sponsor ID
- MVENT / HGWH009
- Conditions
- Metabolic Syndrome, Hypercholesterolemia
- Keywords
- body fat mass gain, Insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 1 Mar 2010 (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 main purpose of this study is to assess the efficacy of metformin in abrogating androgen deprivation therapy (ADT) induced insulin resistance as measured by homeostasis model assessment (HOMAIR) in men with non-metastatic prostate cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: Metformin |
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)
- ≥ 18 years of age
- ECOG ≤ 1
- Histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only (≤ 5 sites of bone metastases only)
- Plan to receive ≥ 6 months continuous androgen deprivation therapy by a GnRH agonist
- Patients who are to receive antiandrogens with GnRH agonists are not excluded from the study. But the form, dose and duration of antiandrogen treatment should be recorded.
Key exclusion criteria (11 listed)
- Visceral involvement
- > 5 sites of bone metastases
- History of confirmed diabetes mellitus (patients with impaired fasting glucose or impaired glucose intolerance will not be excluded) 12
- Treatment with medications that may alter glucose or insulin level within 3 months (including insulin, oral hypoglycemic agents, systemic corticosteroid of any dosage, atypical antipsychotic drugs of any dose)
- Malignant disease other than prostate cancer at the time of enrolment
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 |
|---|---|---|
| MetforminMetformin 1500mg nocte for 6 months | Drug | Metformin |
Primary outcome
The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks
Time frame: 12 and 24 weeks
5 secondary outcomes
To assess the efficacy of metformin in abrogating ADT-induced insulin resistance as measured by whole-body insulin sensitivity index(ISI) at 3 and 6 months
Time frame: 12 and 24 weeks
To assess the efficacy of metformin in reducing the incidence of ADT-induced metabolic syndrome at 3 and 6 months
Time frame: 12 and 24 weeks
To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months
Time frame: 24 weeks
To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months
Time frame: 12 and 24 weeks
To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants
Time frame: 24 weeks
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 15 May 2014.
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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.
Howard Gurney, MBBS, FRACP principal investigator
Westmead Cancer Care Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Metabolic Syndrome and Hypercholesterolemia, run by Western Sydney Local Health District at 1 site in Australia.
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 11 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 15 May 2014. 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 Australia. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks (time frame: 12 and 24 weeks). 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 15 May 2014.