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

Primary Purpose

Metabolic Syndrome, Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Metformin
Sponsored by
Western Sydney Local Health District
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring body fat mass gain, Insulin resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Metformin

Arm Description

Outcomes

Primary Outcome Measures

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

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
To assess the efficacy of metformin in reducing the incidence of ADT-induced metabolic syndrome at 3 and 6 months
To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months
To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months
To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants

Full Information

First Posted
February 26, 2010
Last Updated
May 13, 2014
Sponsor
Western Sydney Local Health District
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1. Study Identification

Unique Protocol Identification Number
NCT01077479
Brief Title
Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
Acronym
MVENT
Official Title
Metformin in Preventing Androgen Deprivation Therapy Induced Insulin Resistance and Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Sydney Local Health District

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Hypercholesterolemia
Keywords
body fat mass gain, Insulin resistance

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 1500mg nocte for 6 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
To assess the efficacy of metformin in reducing ADT-induced percentage body fat mass gain 6 months
Time Frame
24 weeks
Title
To assess the efficacy of metformin in reducing ADT-induced hypercholesterolemia at 3 and 6 months
Time Frame
12 and 24 weeks
Title
To validate measurement of insulin resistance by HOMAIR with euglycemic hyperinsulinemic clamp in a subgroup group of participants
Time Frame
24 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Gurney, MBBS, FRACP
Organizational Affiliation
Westmead Cancer Care Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia

12. IPD Sharing Statement

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

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