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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT05515978
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metformin — DRUG
    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.
  • Lifestyle Modification — BEHAVIORAL
    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

Study Details

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.

Key Dates

Start date
Oct 10, 2022
Status verified
Dec 2025
Primary completion
Oct 20, 2035
Completion
Nov 6, 2036

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin and Lifestyle Modification Arm
    For the metformin arm: metformin will be obtained as a standard of care medication from the patient's general pharmacy. This will be given for a clinical indication (e.g. prediabetes or overweight/obese). It will not be supplied by the study, but billed to Medicare, self pay or 3rd party payer. Lifestyle modification and prediabetes information will be provided via MHC or other electronic means on a quarterly basis.
  • Placebo Comparator: Lifestyle Modification Only Arm
    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.

Primary Outcome Measure

Successful accrual of 100 patients to the pragmatic trial in the first four years [ Time Frame: 4 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Colorado Research CenterAuroraColorado80045
Marjorie McIntyre
[email protected]
303-724-5868
Emily Buchanan
[email protected]
303-724-5912
Thomas Flaig, MD (PRINCIPAL_INVESTIGATOR)
Corbin Eule, MD (SUB_INVESTIGATOR)
Vignesh Narayanan, MD (SUB_INVESTIGATOR)
Cecilia Low Wang Low Wang, MD (SUB_INVESTIGATOR)
Radhika Acharya-Leon, DO (SUB_INVESTIGATOR)
Eryn Callihan, PA (SUB_INVESTIGATOR)
Laura Graham, MD (SUB_INVESTIGATOR)
Brian Kavanagh, MD, MPH (SUB_INVESTIGATOR)
Elizabeth Kessler, MD (SUB_INVESTIGATOR)
Scott Kono, DO (SUB_INVESTIGATOR)
Janet Kukreja, MD (SUB_INVESTIGATOR)
Elaine Lam, MD (SUB_INVESTIGATOR)
Paul Maroni, MD (SUB_INVESTIGATOR)
Sameer Nath, MD (SUB_INVESTIGATOR)
Rebecca Powell, PA (SUB_INVESTIGATOR)
Tyler Robin, MD, PhD (SUB_INVESTIGATOR)
Megan Spradlin, PA (SUB_INVESTIGATOR)
David Strauss, MD (SUB_INVESTIGATOR)
Karley Trautman, NP, RN (SUB_INVESTIGATOR)
Poojitha Valasareddy, MD (SUB_INVESTIGATOR)
Timothy Waxweiler, MD (SUB_INVESTIGATOR)
UCHealth-Southern ColoradoColorado SpringsColorado80863
Elizabeth Graf
[email protected]
Jeffrey Olsen, MD (PRINCIPAL_INVESTIGATOR)
Jeffrey Olsen, MD (SUB_INVESTIGATOR)
Katherine Tzou, MD (SUB_INVESTIGATOR)
UCHealth-Metro DenverDenverColorado80217-3364
Marjorie McIntyre
[email protected]
303-724-5868
UCHealth-Northern ColoradoFort CollinsColorado80521
Sara Twombly
[email protected]
9704911553
Steven Schuster, MD (PRINCIPAL_INVESTIGATOR)
Emily Eiten, PA (SUB_INVESTIGATOR)
Douglas Kemme, MD (SUB_INVESTIGATOR)
James Moore, MD (SUB_INVESTIGATOR)
Joshua Petit, MD (SUB_INVESTIGATOR)
Tricia Smikahl, PA (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Colorado Research Center· Aurora, COUCHealth-Southern Colorado· Colorado Springs, COUCHealth-Metro Denver· Denver, COUCHealth-Northern Colorado· Fort Collins, CO

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