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

Metabolic Syndrome Clinical Trial

— MVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077479
• Other study ID #: HGWH009
• Status: Completed
• Phase: Phase 2
• First received: February 26, 2010
• Last updated: May 13, 2014
• Start date: February 2010
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypercholesterolemia
• Insulin Resistance
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Drug:
• Metformin
Metformin 1500mg nocte for 6 months

Locations

Country	Name	City	State
Australia	Westmead Hospital	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Western Sydney Local Health District

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage change in insulin resistance measured by homeostasis model assessment (HOMAIR) from baseline to 12 and 24 weeks		12 and 24 weeks	No
Secondary	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	No
Secondary	To assess the efficacy of metformin in reducing the incidence of ADT-induced metabolic syndrome at 3 and 6 months		12 and 24 weeks	No
Secondary	To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months		24 weeks	No
Secondary	To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months		12 and 24 weeks	No
Secondary	To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants		24 weeks	No