Recruiting
Early Phase 1

Metformin

Sponsor:

University of Colorado, Denver

Code:

NCT05515978

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Metformin

Lifestyle Modification

Study Details

Brief 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

Prostate Cancer

Study ID

NCT05515978

Start date

Oct 10, 2022

Status verified date

Dec, 2025

Completion date

Nov 6, 2036

Anticipated

Primary completion date

Oct 20, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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:

1. Provision to sign and date the consent form in MHC or otherwise via Epic.
2. Subjects must have an MHC Account to participate in the study
3. Be a male aged ≥18 years of age on day of signing the informed consent.
4. 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
5. Have a prostate cancer diagnosis
6. Have a clinical relationship with a participating provider at a UCHealth facility.

Exclusion Criteria:

1. 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):
1. Metformin
2. Insulin
3. Glipizide
4. Glyburide
5. Glimepiride
6. Pioglitazone
7. Rosiglitazone
8. Sitagliptin
9. Saxagliptin
10. Linagliptin
11. Alogliptin
12. Canagliflozin
13. Dapagliflozin
14. Empagliflozin
15. Ertugliflozin
16. Liraglutide
17. Dulaglutide
18. Semaglutide
19. Exenatide
20. Lixisenatide
21. Nateglinide
22. Repaglinide
23. Tirzepatide
2. Contraindication for metformin use which include any of the following which are exclusionary (in Epic will use most recent lab values):

1. Estimated glomerular filtration rate (eGFR) of < 50 ml/minute (calculated according to the formula utilized within Epic).
2. Known Total Bilirubin ≥3 mg/dL)
3. Diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74)
4. Diagnosis of alcohol related disorders (ICD10: F10)
5. Metformin allergy in Epic (ICD10: T50.995A)
3. 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.
4. Taking any medication with a known class D or higher drug interaction with metformin, including:

1. Cimetidine
2. Dolutegravir
3. Patiromer
4. Ranolazine
5. Tafenoquine
5. The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including:

1. Topiramate
2. Dichlorphenamide
3. Acetazolamide
4. Methazolamide
5. Dorzolamide
6. Brinzolamide
7. Dichlorphenamide
8. Sultiame
9. Zonisamide
10. Indisulam
6. Any treating investigator concern, related to tolerance, safety, adherence or for any other reason

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Metformin

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

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

Primary outcome measure

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

Central Contacts and Locations

Locations

Colorado Research Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Principal Investigator:

Thomas Flaig, MD

UCHealth-Southern Colorado

Recruiting

Colorado Springs, Colorado, United States, 80863

Contacts

Principal Investigator:

Jeffrey Olsen, MD

UCHealth-Metro Denver

Recruiting

Denver, Colorado, United States, 80217-3364

Contacts

UCHealth-Northern Colorado

Recruiting

Fort Collins, Colorado, United States, 80521

Contacts

Principal Investigator:

Steven Schuster, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Jun 2, 2026

Last verified

Dec, 2025

Keywords

  • Pragmatic
  • Prostate
  • Cancer
  • Prostate Cancer
  • Metformin
  • Lifestyle
  • Lifestyle changes
  • Lifestyle Modifications

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-06-02.