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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Howard Gurney, Western Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01077479
First received: February 26, 2010
Last updated: May 13, 2014
Last verified: May 2014
  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 Intervention Phase
Metabolic Syndrome
Hypercholesterolemia
Drug: Metformin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Western Sydney Local Health District:

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 ]

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 ]

Enrollment: 28
Study Start Date: February 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin Drug: Metformin
Metformin 1500mg nocte for 6 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077479

Locations
Australia, New South Wales
Westmead Hospital
Sydney, New South Wales, Australia, 2145
Sponsors and Collaborators
Western Sydney Local Health District
Investigators
Principal Investigator: Howard Gurney, MBBS, FRACP Westmead Cancer Care Centre
  More Information

No publications provided

Responsible Party: Howard Gurney, A/Prof Howard Gurney, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01077479     History of Changes
Other Study ID Numbers: HGWH009
Study First Received: February 26, 2010
Last Updated: May 13, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Western Sydney Local Health District:
body fat mass gain
Insulin resistance

Additional relevant MeSH terms:
Hypercholesterolemia
Insulin Resistance
Metabolic Syndrome X
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Androgens
Insulin
Metformin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 26, 2014