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

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

October 10, 2022

Primary Completion Date

October 20, 2035

Study Completion Date

November 6, 2036

Conditions
Prostate Cancer
Interventions
DRUG

Metformin

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.

BEHAVIORAL

Lifestyle 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"

Trial Locations (4)

80045

RECRUITING

Colorado Research Center, Aurora

80521

RECRUITING

UCHealth-Northern Colorado, Fort Collins

80863

RECRUITING

UCHealth-Southern Colorado, Colorado Springs

80217-3364

RECRUITING

UCHealth-Metro Denver, Denver

All Listed Sponsors
lead

University of Colorado, Denver

OTHER