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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Aurora

Colorado Research Center, Aurora, Colorado, United States, 80045

Colorado Springs

UCHealth-Southern Colorado, Colorado Springs, Colorado, United States, 80863

Denver

UCHealth-Metro Denver, Denver, Colorado, United States, 80217-3364

Fort Collins

UCHealth-Northern Colorado, Fort Collins, Colorado, United States, 80521

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 1. On therapy for diabetes including any of the following alone or in combination medications (diet controlled or managed diabetes is allowed - e.g.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Colorado, Denver,

Thomas Flaig, MD, PRINCIPAL_INVESTIGATOR, Colorado Research Center

Study Record Dates

2036-11-06