NCT05515978 · University of Colorado, Denver
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
(PragMet)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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):
- Glimepiride
- Pioglitazone
- Rosiglitazone
- Sitagliptin
- Saxagliptin
- Linagliptin
- Canagliflozin
- Dapagliflozin
- Empagliflozin
- Ertugliflozin
- Liraglutide
- Dulaglutide
- Semaglutide
- Lixisenatide
- Nateglinide
- Repaglinide
- Tirzepatide
- Contraindication for metformin use which include any of the following which are exclusionary (in Epic will use most recent lab values):
- Estimated glomerular filtration rate (eGFR) of \< 50 ml/minute (calculated according to the formula utilized within Epic).
- Known Total Bilirubin ≥3 mg/dL)
- Diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74)
- Diagnosis of alcohol related disorders (ICD10: F10)
- Metformin allergy in Epic (ICD10: T50.995A)
- Non-English-speaking patient until Spanish language consent form and relevant materials can be made available. Due to the novel aspect of this trial, we plan to get some experience in treating approximately the first 50 patients, make any changes needed in the study operations and then implement a Spanish consent, as feasible.
- Taking any medication with a known class D or higher drug interaction with metformin, including:
- Dolutegravir
- Tafenoquine
- The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including:
- Dichlorphenamide
- Acetazolamide
- Methazolamide
- Dorzolamide
- Brinzolamide
- Dichlorphenamide
- Any treating investigator concern, related to tolerance, safety, adherence or for any other reason
Where
- Aurora, Colorado
- Colorado Springs, Colorado
- Denver, Colorado
- Fort Collins, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 2, 2026 · Source of record for eligibility and locations