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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01077479




Registration number
NCT01077479
Ethics application status
Date submitted
26/02/2010
Date registered
1/03/2010
Date last updated
15/05/2014

Titles & IDs
Public title
Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
Scientific title
Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
Secondary ID [1] 0 0
HGWH009
Universal Trial Number (UTN)
Trial acronym
MVENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 0 0
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Metformin

Experimental: Metformin -


Treatment: Drugs: Metformin
Metformin 1500mg nocte for 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks
Timepoint [1] 0 0
12 and 24 weeks
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
12 and 24 weeks
Secondary outcome [2] 0 0
To assess the efficacy of metformin in reducing the incidence of ADT-induced metabolic syndrome at 3 and 6 months
Timepoint [2] 0 0
12 and 24 weeks
Secondary outcome [3] 0 0
To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months
Timepoint [4] 0 0
12 and 24 weeks
Secondary outcome [5] 0 0
To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants
Timepoint [5] 0 0
24 weeks

Eligibility
Key inclusion criteria
* = 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2013
Sample size
Target
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Westmead Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/study/NCT01077479
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Howard Gurney, MBBS, FRACP
Address 0 0
Westmead Cancer Care Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01077479