RecruitingEarly Phase 1NCT05515978

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

Sponsor

University of Colorado, Denver

Enrollment

100 participants

Start Date

Oct 10, 2022

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

Summary

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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether metformin — a common diabetes medication — can help prostate cancer patients who have pre-diabetes (blood sugar slightly elevated, but not yet diabetes) or are overweight. Some research suggests metformin may slow prostate cancer progression in addition to improving blood sugar and metabolism. **You may be eligible if...** - You are a male aged 18 or older with prostate cancer - You have pre-diabetes (HbA1c between 5.7–6.4%) and/or a BMI of 25 or higher - You have access to an online patient portal (Epic MyChart/My Health Connection) - Your doctor considers it appropriate for you to take metformin **You may NOT be eligible if...** - You have been diagnosed with Type 2 diabetes or are already on metformin - You are already at your target blood sugar and healthy weight - You have significant kidney problems (metformin is not safe for severely impaired kidneys) - You do not have a patient portal account or the means to enroll electronically - You are not a male or do not have prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetformin

Metformin is a medication used to treat type 2 diabetes, gestational diabetes, and prediabetes. In this study, patients on the Metformin arm will be started on 850 mg daily for 2 weeks, then escalated to a final dose of 850 mg twice daily, which is lower than the maximum recommended dose of 2550 mg total daily.

BEHAVIORALLifestyle Modification

Patients randomized to this arm will receive standard lifestyle modification recommendations. This will include the general recommendation to increase exercise level mildly, after discussing with the medical provider. There is a potential low-level risk in increasing one's exercise levels. Here are some examples of the educational material from the American Diabetes Association website, and topics will be rotated on quarterly basis: Healthy eating: https://www.diabetes.org/nutrition/healthy-food-choices-made-easy Prediabetes: https://www.diabetes.org/diabetes-risk/prediabetes Fitness: https://www.diabetes.org/fitness/get-and-stay-fit Weight loss: https://www.diabetes.org/fitness/weight-loss