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Clinical trialNCT05515978RecruitingEarly phase 1Interventional

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

SponsorUniversity of Colorado, DenverEnrollment100Prostate Cancer
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Colorado Research Center

    Aurora, Colorado, United States

    Brian Kavanagh, MD, MPHCecilia Low Wang Low Wang, MDCorbin Eule, MDDavid Strauss, MDElaine Lam, MDElizabeth Kessler, MDEryn Callihan, PAJanet Kukreja, MDKarley Trautman, NP, RNLaura Graham, MDMegan Spradlin, PAPaul Maroni, MDPoojitha Valasareddy, MDRadhika Acharya-Leon, DORebecca Powell, PASameer Nath, MDScott Kono, DOThomas Flaig, MDTimothy Waxweiler, MDTyler Robin, MD, PhDVignesh Narayanan, MD
    Recruiting
  • Uchealth-Southern Colorado

    Colorado Springs, Colorado, United States

    Jeffrey Olsen, MDKatherine Tzou, MD
    Recruiting
  • Uchealth-Metro Denver

    Denver, Colorado, United States

    Recruiting
  • Uchealth-Northern Colorado

    Fort Collins, Colorado, United States

    Douglas Kemme, MDEmily Eiten, PAJames Moore, MDJoshua Petit, MDSteven Schuster, MDTricia Smikahl, PA
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Metformin →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
10 Oct 2022
Primary completion
20 Oct 2035
Completion
6 Nov 2036
Last update posted
2 Jun 2026
Registered enrollment
100
Registry id
NCT05515978
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.