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

Phase 2

Completed

• Conditions: Metabolic Syndrome; Hypercholesterolemia
• Interventions: Drug: Metformin

• Registration Number: NCT01077479
• Lead Sponsor: Western Sydney Local Health District

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 available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-26
• Study First Submitted QC: 2010-02-26
• Study First Posted: 2010-03-01
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-13
• Last Update Posted: 2014-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	-

Primary Outcome Measures

Name	Time	Method
The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks	12 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
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	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

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Sydney, New South Wales, Australia