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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | Metformin 1500mg nocte for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks | 12 and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 and 24 weeks | |
| To assess the efficacy of metformin in reducing the incidence of ADT-induced metabolic syndrome at 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Howard Gurney, MBBS, FRACP | Westmead Cancer Care Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Hospital | Sydney | New South Wales | 2145 | Australia |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D006937 | Hypercholesterolemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| 12 and 24 weeks |
| To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months | 24 weeks |
| To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months | 12 and 24 weeks |
| To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants | 24 weeks |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |