Actively Recruiting
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Led by University of Colorado, Denver · Updated on 2025-12-04
100
Participants Needed
4
Research Sites
734 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male aged 18 years or older at time of consent
- Have a clinical diagnosis of prostate cancer
- Have impaired glucose tolerance defined by an HbA1c of 5.7 to 6.4% in the past year and/or a BMI of 25 kg/m2 or higher in the past year
- Have a clinical relationship with a participating UCHealth provider
- Have an active My Health Connection (MHC) account to provide electronic consent
You will not qualify if you...
- Currently treated with any diabetes medication including metformin, insulin, glipizide, glyburide, glimepiride, pioglitazone, rosiglitazone, sitagliptin, saxagliptin, linagliptin, alogliptin, canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, liraglutide, dulaglutide, semaglutide, exenatide, lixisenatide, nateglinide, repaglinide, or tirzepatide
- Estimated glomerular filtration rate (eGFR) less than 50 ml/minute
- Total bilirubin of 3 mg/dL or higher
- Diagnosis of liver fibrosis or cirrhosis
- Diagnosis of alcohol-related disorders
- Allergy to metformin
- Non-English speaking until Spanish materials are available
- Taking medications with class D or higher interaction with metformin, including cimetidine, dolutegravir, patiromer, ranolazine, or tafenoquine
- Using carbonic anhydrase inhibitors such as topiramate, dichlorphenamide, acetazolamide, methazolamide, dorzolamide, brinzolamide, sultiame, zonisamide, or indisulam
- Any investigator concerns regarding safety, tolerance, or adherence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Colorado Research Center
Aurora, Colorado, United States, 80045
Actively Recruiting
2
UCHealth-Southern Colorado
Colorado Springs, Colorado, United States, 80863
Actively Recruiting
3
UCHealth-Metro Denver
Denver, Colorado, United States, 80217-3364
Actively Recruiting
4
UCHealth-Northern Colorado
Fort Collins, Colorado, United States, 80521
Actively Recruiting
Research Team
E
Emily Buchanan
CONTACT
M
Marjorie McIntyre
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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