Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Recruiting · NCT05515978 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Colorado, Denver
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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):
- Metformin
- Insulin
- Glipizide
- Glyburide
- Glimepiride
- Pioglitazone
- Rosiglitazone
- Sitagliptin
- Saxagliptin
- Linagliptin
- Alogliptin
- Canagliflozin
- Dapagliflozin
- Empagliflozin
- Ertugliflozin
- Liraglutide
- Dulaglutide
- Semaglutide
- Exenatide
- 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:
- Cimetidine
- Dolutegravir
- Patiromer
- Ranolazine
- Tafenoquine
- The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including:
- Topiramate
- Dichlorphenamide
- Acetazolamide
- Methazolamide
- Dorzolamide
- Brinzolamide
- Dichlorphenamide
- Sultiame
- Zonisamide
- Indisulam
- Any treating investigator concern, related to tolerance, safety, adherence or for any other reason
Where it is running
4 locations listed across 1 US state.
- Colorado Research Center - Aurora, Colorado, United States
- UCHealth-Southern Colorado - Colorado Springs, Colorado, United States
- UCHealth-Metro Denver - Denver, Colorado, United States
- UCHealth-Northern Colorado - Fort Collins, Colorado, United States