Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Status:
Not yet recruiting
Trial end date:
2036-11-06
Target enrollment:
Participant gender:
Summary
Metformin is used widely in the treatment of type 2 diabetes. It has off-label indications
for use in the prevention of diabetes and in hyperinsulinar obesity. In medical practices,
the implementation of metformin for these off-label indications is variable, often at the
level of the provider. Multiple retrospective investigations have also shown a clinical
benefit in men with prostate cancer who are incidentally treated with metformin.
This pragmatic study will test the feasibility of enrolling patients who have glucose
intolerance (as defined by HbA1c of 5.7-6.4%) and/or who have increased BMI (BMI greater than
or equal to 25 kg/m2) to a randomized pragmatic study of metformin plus lifestyle
modification information versus lifestyle modification information only. For purposes of the
scope of this project and the study's feasibility, this will be implemented in a group of
prostate cancer patients, who may have additional benefits from metformin.