Metformin and Lifestyle Modification for the Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients
This early phase I trial compares patients who make changes in lifestyle and also take a medicine called metformin to reduce the risk of metabolic disorders. Metformin is a medicine that works to lower the amount of sugar in the blood of people with diabetes or prediabetes. It does this by lowering the amount of sugar produced in the liver. Additionally, when patients have elevated blood sugar levels there are actions they can take to reduce their chance of developing diabetes, including changing their diet and exercise habits. This study may help researchers learn more about how metformin and lifestyle modification work in people with prostate cancer and metabolic disorders.
Inclusion Criteria
- 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): * Hemoglobin A1C (HbA1c) of 5.7 – 6.4 % * Body mass index (BMI) >= 25 kg/m^2
- Have a prostate cancer diagnosis
- Have a clinical relationship and planned visit 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) * 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
Additional locations may be listed on ClinicalTrials.gov for NCT05515978.
Locations matching your search criteria
United States
Colorado
Aurora
Colorado Springs
Denver
Fort Collins
Greeley
Highlands Ranch
Lone Tree
Loveland
PRIMARY OBJECTIVE:
I. To assess the feasibility of a randomized, pragmatic, adaptive interventional trial in a multi-center hospital system with a goal accrual of 100 evaluable patients in 4 years.
SECONDARY OBJECTIVES:
I. To determine the effectiveness of metformin prescribed in a pragmatic trial on key metabolic and physiologic parameters. (Effectiveness)
II. To determine the effectiveness of metformin prescribed in a pragmatic trial on the development of diabetes. (Effectiveness)
III. To determine the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse cardiac events (MACE) and major adverse limb events (MALE). (Effectiveness)
IV. To determine the effectiveness of metformin prescribed on a pragmatic trial in progression-free survival defined as doubling of prostate-specific antigen (PSA) level or all-cause mortality. (Effectiveness)
V. To determine the effectiveness of metformin prescribed on a pragmatic trial on PSA response of prostate cancer. (Effectiveness)
VI. To determine the effectiveness of metformin prescribed on a pragmatic trial on overall and prostate cancer specific survival. (Effectiveness)
VII. To determine the safety of providing metformin via this pragmatic approach. (Safety)
EXPLORATORY OBJECTIVES:
I. To determine the proportion of patients approached who enroll and the characteristics and representativeness of those enrolled. (Reach)
II. To determine the accuracy of the Epic screening process to identify eligible patients and communicate this to a participating investigator. (Implementation)
III. To determine the effectiveness of different approaches to presenting the consent to patients in My Health Connection (MHC)/Epic with added coordinator facilitation when required. (Implementation)
IV. To determine the time period required to identify and enroll 100 eligible patients. (Implementation)
V. To determine the accuracy of TriNetX in predicting the number of eligible patients identified each month. (Implementation)
VI. To determine the number and proportion of patients who adhere to the assigned treatment plan. (Adherence)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive metformin orally (PO) once daily (QD) for 2 weeks, then twice daily (BID) on study in the absence of disease progression or unacceptable toxicity. Patients also receive educational material on lifestyle modification to reduce the risk of diabetes via MHC/Epic or email on study.
ARM II: Patients receive educational material on lifestyle modification to reduce the risk of diabetes via MHC/Epic or email on study.
After completion if study treatment, patients are followed up to 10 years.
Trial PhasePhase O
Trial Typetreatment
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorThomas W. Flaig
- Primary ID19-1536
- Secondary IDsNCI-2021-05911
- ClinicalTrials.gov IDNCT05515978