Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients

Recruiting now · Early Phase 1

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05515978

Run by

University of Colorado, Denver

People needed

100

Starts

2022-10-10

Expected to finish

2036-11-06

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• In order to be eligible to participate in this study, an individual must meet all of the following criteria. The patients will be screening for eligibility and offered an electronic consent via the Epic medical record and the patient portal (My Health Connection - MHC) or otherwise through Epic:
• Provision to sign and date the consent form in MHC or otherwise via Epic.
• Subjects must have an MHC Account to participate in the study
• Be a male aged ≥18 years of age on day of signing the informed consent.
• Impaired glucose tolerance and/or overweight, and appropriate to receive metformin, meeting at least one of the following in the last year (timing relative to the consent presentation not start of therapy):
• HbA1c of 5.7 - 6.4 %
• BMI≥25 kg/m\^2
• Have a prostate cancer diagnosis
• Have a clinical relationship with a participating provider at a UCHealth facility.

You may not qualify if…

• On therapy for diabetes including any of the following alone or in combination medications (diet controlled or managed diabetes is allowed - e.g.
• diagnosis of Diabetes, but without an active prescription for anti-glycemic medication):
• Metformin
• Insulin
• Glipizide
• Glyburide
• Glimepiride
• Pioglitazone
• Rosiglitazone
• Sitagliptin
• Saxagliptin
• Linagliptin
• Alogliptin
• Canagliflozin
• Dapagliflozin
• Empagliflozin
• Ertugliflozin
• Liraglutide
• Dulaglutide
• Semaglutide
• Exenatide
• Lixisenatide
• Nateglinide
• Repaglinide
• Tirzepatide

Where it is running

• Colorado Research Center — Aurora, Colorado, United States (enrolling)
• UCHealth-Southern Colorado — Colorado Springs, Colorado, United States (enrolling)
• UCHealth-Metro Denver — Denver, Colorado, United States (enrolling)
• UCHealth-Northern Colorado — Fort Collins, Colorado, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.