Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome | RxWiki

Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Metabolic Syndrome Hypercholesterolemia
Intervention	Drug: Metformin
Phase	Phase 2
Sponsor	Western Sydney Local Health District
Responsible Party	Western Sydney Local Health District
ClinicalTrials.gov Identifier	NCT01077479
First Received	February 26, 2010
Last Updated	May 3, 2013
Last verified	May 2013

Tracking Information[ + expand ][ + ]

First Received Date	February 26, 2010
Last Updated Date	May 3, 2013
Start Date	February 2010
Estimated Primary Completion Date	June 2013
Current Primary Outcome Measures	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] [Designated as safety issue: No]
Current Secondary Outcome Measures	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] [Designated as safety issue: No] 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] [Designated as safety issue: No] To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months [Time Frame: 24 weeks] [Designated as safety issue: No] To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months [Time Frame: 12 and 24 weeks] [Designated as safety issue: No] To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants [Time Frame: 24 weeks] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
Official Title	Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Condition	Metabolic Syndrome Hypercholesterolemia
Intervention	Drug: Metformin Metformin 1500mg nocte for 6 months
Study Arm (s)	Experimental: Metformin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Active, not recruiting
Estimated Enrollment	28
Estimated Completion Date	June 2013
Estimated Primary Completion Date	June 2013
Eligibility Criteria	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) 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
Gender	Male
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Australia

Administrative Information[ + expand ][ + ]

NCT Number	NCT01077479
Other Study ID Numbers	HGWH009
Has Data Monitoring Committee	Yes
Information Provided By	Western Sydney Local Health District
Study Sponsor	Western Sydney Local Health District
Collaborators	Not Provided
Investigators	Principal Investigator: Howard Gurney, MBBS, FRACP Westmead Cancer Care Centre
Verification Date	May 2013

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