RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-10-17
Study Completion:2036-11-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05515978

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision to sign and date the consent form in MHC or otherwise via Epic.
  2. 2. Subjects must have an MHC Account to participate in the study
  3. 3. Be a male aged ≥18 years of age on day of signing the informed consent.
  4. 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):
  5. * HbA1c of 5.7 - 6.4 %
  6. * BMI≥25 kg/m\^2
  7. 5. Have a prostate cancer diagnosis
  8. 6. Have a clinical relationship with a participating provider at a UCHealth facility.
  1. 1. On therapy for diabetes including any of the following alone or in combination medications (diet controlled or managed diabetes is allowed - e.g.
  2. 1. Metformin
  3. 2. Insulin
  4. 3. Glipizide
  5. 4. Glyburide
  6. 5. Glimepiride
  7. 6. Pioglitazone
  8. 7. Rosiglitazone
  9. 8. Sitagliptin
  10. 9. Saxagliptin
  11. 10. Linagliptin
  12. 11. Alogliptin
  13. 12. Canagliflozin
  14. 13. Dapagliflozin
  15. 14. Empagliflozin
  16. 15. Ertugliflozin
  17. 16. Liraglutide
  18. 17. Dulaglutide
  19. 18. Semaglutide
  20. 19. Exenatide
  21. 20. Lixisenatide
  22. 21. Nateglinide
  23. 22. Repaglinide
  24. 23. Tirzepatide
  25. 2. Contraindication for metformin use which include any of the following which are exclusionary (in Epic will use most recent lab values):
  26. 1. Estimated glomerular filtration rate (eGFR) of \< 50 ml/minute (calculated according to the formula utilized within Epic).
  27. 2. Known Total Bilirubin ≥3 mg/dL)
  28. 3. Diagnosis of fibrosis or cirrhosis of the liver (ICD10: K74)
  29. 4. Diagnosis of alcohol related disorders (ICD10: F10)
  30. 5. Metformin allergy in Epic (ICD10: T50.995A)
  31. 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.
  32. 4. Taking any medication with a known class D or higher drug interaction with metformin, including:
  33. 1. Cimetidine
  34. 2. Dolutegravir
  35. 3. Patiromer
  36. 4. Ranolazine
  37. 5. Tafenoquine
  38. 5. The use of any carbonic anhydrase inhibitors since they are a risk factor for lactic acidosis, including:
  39. 1. Topiramate
  40. 2. Dichlorphenamide
  41. 3. Acetazolamide
  42. 4. Methazolamide
  43. 5. Dorzolamide
  44. 6. Brinzolamide
  45. 7. Dichlorphenamide
  46. 8. Sultiame
  47. 9. Zonisamide
  48. 10. Indisulam
  49. 6. Any treating investigator concern, related to tolerance, safety, adherence or for any other reason

Contacts and Locations

Study Contact

Jaquelyn O&#39;Brien
CONTACT
7208488879
jaquelyn.OBrien@cuanschutz.edu
Robyn Swing
CONTACT
7208480607
robyn.swing@cuanschutz.edu

Principal Investigator

Thomas Flaig, MD
PRINCIPAL_INVESTIGATOR
Colorado Research Center

Study Locations (Sites)

Colorado Research Center
Aurora, Colorado, 80045
United States
UCHealth-Southern Colorado
Colorado Springs, Colorado, 80863
United States
UCHealth-Metro Denver
Denver, Colorado, 80217-3364
United States
UCHealth-Northern Colorado
Fort Collins, Colorado, 80521
United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Thomas Flaig, MD, PRINCIPAL_INVESTIGATOR, Colorado Research Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-17
Study Completion Date2036-11-06

Study Record Updates

Study Start Date2022-10-17
Study Completion Date2036-11-06

Terms related to this study

Additional Relevant MeSH Terms

  • Prostate Cancer