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RecruitingEarly Phase 1

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

A Randomized, Pragmatic, Adaptive Trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 10 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "In this study, subjects with prostate cancer will be randomized to metformin plus educational material for lifestyle modification versus educational material for lifestyle modification alone and followed for up to 10 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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: 1. Provision to sign and date the consent form in MHC or otherwise via Epic. 2. Subjects must have an MHC Account to participate in the study 3. Be a male aged ≥18 years of age on day of signing the informed consent. 4. 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 5. Have a prostate cancer diagnosis 6. Have a clinical relationship with a participating provider at a UCHealth facility. Exclusion Criteria: 1. 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): 1. Metformin 2. Insulin 3. Glipizide 4. Glyburide 5. Glimepiride 6. Pioglitazone 7. Rosiglitazone 8. Sitagliptin 9. Saxagliptin 10. Linagliptin 11. Alogliptin 12. Canagliflozin 13. Dapagliflozin 14. Empagliflozin 15. Ertugliflozin 16. Liraglutide 17. Dulaglutide 18. Semaglutide 19. Exenatide 20. Lixisenatide 21. Nateglinide 22. Repaglinide 23. Tirzepatide 2. Contraindication for metformin use which include any of the following which are exclusionary (in Epic will use most recent lab values): 1. Estimated glomerular filtration rate (eGFR) of \< 50 ml/minute (calculated according to the formula utilized within Epic). 2. Known Total Bilirubin ≥3 mg/dL) 3. Diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74) 4. Diagnosis of alcohol related disorders (ICD10: F10) 5. Metformin allergy in Epic (ICD10: T50.995A) 3. 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. 4. Taking any medication with a known class D or higher drug interaction with metformin, including: 1. Cimetidine 2. Dolutegravir 3. Patiromer 4. Ranolazine 5. Tafenoquine 5. The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including: 1. Topiramate 2. Dichlorphenamide 3. Acetazolamide 4. Methazolamide 5. Dorzolamide 6. Brinzolamide 7. Dichlorphenamide 8. Sultiame 9. Zonisamide 10. Indisulam 6. Any treating investigator concern, related to tolerance, safety, adherence or for any other reason

Study sites (4)

CO