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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: Recruiting Early Phase 1 study of Prostate Cancer, sponsored by University of Colorado, Denver.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Once there are 6 months of follow-up data on the first 100 patients, a formal analysis will be done to determine the completeness of data and the potential for a powered study. Outcome measure was amended January 2025.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-10-10 |
| Est. Completion | 2036-11-06 |
| Phase | Early Phase 1 |
What NCT05515978 shows while recruiting
NCT05515978 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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
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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.
Where NCT05515978's enrollment target sits among peer trials
100 330th of 735 higher than 389 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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