NCT05515978Active, not recruitingEarly phase 1

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

A Randomized, Pragmatic, Adaptive Trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry): Active, not recruiting
Phase (registry): Early phase 1
Study type: Interventional
Enrollment: 100 (estimated)
First submitted: 17 May 2021
Start date: 10 Oct 2022
Primary completion date: 20 Oct 2035
Lead sponsor: University of Colorado, Denver
Diseases: Prostate cancer
NCT number: NCT05515978

What you commit to

Study type: Interventional · Early phase 1
Planned participants: 100
From 10 Oct 2022 to the primary completion date, 20 Oct 2035
4 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Taking any medication with a known class D or higher drug interaction with metformin, including:
- Cimetidine
- Dolutegravir
- Patiromer
- Ranolazine
- Tafenoquine
The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including:
- Topiramate
- Dichlorphenamide
- Acetazolamide
- Methazolamide
- Dorzolamide
- Brinzolamide
- Dichlorphenamide
- Sultiame
- Zonisamide
- Indisulam

Other illness

On therapy for diabetes including any of the following alone or in combination medications (diet controlled or managed diabetes is allowed - e.g.
- diagnosis of Diabetes, but without an active prescription for anti-glycemic medication):
- Metformin
- Insulin
- Glipizide
- Glyburide
- Glimepiride
- Pioglitazone
- Rosiglitazone
- Sitagliptin
- Saxagliptin
- Linagliptin
- Alogliptin
- Canagliflozin
- Dapagliflozin
- Empagliflozin
- Ertugliflozin
- Liraglutide
- Dulaglutide
- Semaglutide
- Exenatide
- Lixisenatide
- Nateglinide
- Repaglinide
- Tirzepatide

Lab values

Contraindication for metformin use which include any of the following which are exclusionary (in Epic will use most recent lab values):
- Estimated glomerular filtration rate (eGFR) of \< 50 ml/minute (calculated according to the formula utilized within Epic).
- Known Total Bilirubin ≥3 mg/dL)
- Diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74)
- Diagnosis of alcohol related disorders (ICD10: F10)
- Metformin allergy in Epic (ICD10: T50.995A)

Other

Non-English-speaking patient until Spanish language consent form and relevant materials can be made available. Due to the novel aspect of this trial, we plan to get some experience in treating approximately the first 50 patients, make any changes needed in the study operations and then implement a Spanish consent, as feasible.
Any treating investigator concern, related to tolerance, safety, adherence or for any other reason

Who the study is looking for

In order to be eligible to participate in this study, an individual must meet all of the following criteria. The patients will be screening for eligibility and offered an electronic consent via the Epic medical record and the patient portal (My Health Connection - MHC) or otherwise through Epic:
Provision to sign and date the consent form in MHC or otherwise via Epic.
Subjects must have an MHC Account to participate in the study
Be a male aged ≥18 years of age on day of signing the informed consent.
Impaired glucose tolerance and/or overweight, and appropriate to receive metformin, meeting at least one of the following in the last year (timing relative to the consent presentation not start of therapy):
- HbA1c of 5.7 - 6.4 %
- BMI≥25 kg/m\^2
Have a prostate cancer diagnosis
Have a clinical relationship with a participating provider at a UCHealth facility.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Colorado Research Center Coordinator of this site? Confirm its status	Aurora	United States	Unknown status
UCHealth-Southern Colorado Coordinator of this site? Confirm its status	Colorado Springs	United States	Unknown status
UCHealth-Metro Denver Coordinator of this site? Confirm its status	Denver	United States	Unknown status
UCHealth-Northern Colorado Coordinator of this site? Confirm its status	Fort Collins	United States	Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.