Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT05515978 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study of Prostate Cancer, sponsored by University of Colorado, Denver.

Recruiting
Registry status
Early Phase 1
Development phase
100
Enrollment target
4
Study locations

NCT05515978 is a Early Phase 1 study of Prostate Cancer that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 100 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (84% lower). The trial reports 4 study locations across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT05515978, a Early Phase 1 study of Prostate Cancer, is actively recruiting participants, sponsored by University of Colorado, Denver.

RECRUITING
Registry status
Early Phase 1
Development phase
100 participants
Enrollment target
4
Study locations

Study 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.

Conditions Studied

Prostate Cancer

Interventions

  • DRUG Metformin
  • BEHAVIORAL Lifestyle Modification

Study Locations (4)

Colorado

  • Colorado Research Center - Aurora
  • UCHealth-Southern Colorado - Colorado Springs
  • UCHealth-Metro Denver - Denver
  • UCHealth-Northern Colorado - Fort Collins

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2022-10-10
Est. Completion 2036-11-06
Phase Early Phase 1

Sponsor

University of Colorado, Denver

1,283 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05515978

The ClinicalTrials.gov registry entry for NCT05515978 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (84% lower). The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Metformin is the first listed.

NCT05515978 reports 4 study locations spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT05515978 about?

NCT05515978 is a clinical study titled "Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients". 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. Multi...

What is the current status of trial NCT05515978?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2022-10-10. Estimated completion is 2036-11-06.

What conditions does trial NCT05515978 study?

This clinical trial studies the following conditions: Prostate Cancer.

What interventions are being tested in trial NCT05515978?

The interventions under investigation include: Metformin (DRUG), Lifestyle Modification (BEHAVIORAL).

Who is sponsoring clinical trial NCT05515978?

This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05515978 being conducted?

This trial has 4 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostate Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Prostate Cancer

All registered trials for this condition

Colorado

All trials with a study site in Colorado

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.