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Biguanide

Metformin for Prostate Cancer Patients with Glucose Intolerance or Overweight

Phase < 1
Recruiting
Led By Thomas Flaig, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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/m2, Have a prostate cancer diagnosis, Have a clinical relationship with a participating provider at a UCHealth facility
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights

Study Summary

This trial will test if it is feasible to enroll prostate cancer patients who have glucose intolerance or are overweight to a study where they receive metformin to see if it has any benefits.

Who is the study for?
Men over 18 with prostate cancer and either glucose intolerance (HbA1c of 5.7-6.4%) or a BMI≥25 kg/m2 can join this study if they have an MHC Account, consent to participate, and are under the care of a participating UCHealth provider. They must not be on certain drugs that interact badly with metformin, have severe kidney issues, liver diseases like cirrhosis or fibrosis, alcohol disorders, or allergies to metformin.Check my eligibility
What is being tested?
This trial is checking if adding metformin to lifestyle changes helps control blood sugar better than just lifestyle advice in men with prostate cancer who also have high blood sugar levels or are overweight. Participants will randomly receive either both treatments or only lifestyle modification information.See study design
What are the potential side effects?
Metformin may cause stomach upset like diarrhea, nausea; it can also lead to low vitamin B12 levels and rarely might cause a dangerous condition called lactic acidosis where too much acid builds up in the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 18 or older.
Select...
You have high blood sugar or are overweight, and can take metformin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Successful accrual of 200 patients to the pragmatic trial in the first two years
Secondary outcome measures
Adherence: To determine the number and proportion of patients who adhere to the assigned treatment plan.
Determine the number of additional diabetes medications initiated
Determine the number of new diagnoses of diabetes
+23 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Metformin and Lifestyle Modification ArmActive Control2 Interventions
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.
Group II: Lifestyle Modification Only ArmPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,492 Total Patients Enrolled
13 Trials studying Prostate Cancer
2,826 Patients Enrolled for Prostate Cancer
Thomas Flaig, MDPrincipal InvestigatorColorado Research Center
1 Previous Clinical Trials

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT05515978 — Phase < 1
Prostate Cancer Research Study Groups: Metformin and Lifestyle Modification Arm, Lifestyle Modification Only Arm
Prostate Cancer Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT05515978 — Phase < 1
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05515978 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently in search of participants for this research project?

"Analysis of the clinicaltrials.gov webpage suggests that this trial is not currently accepting new patients. This study was initially posted on January 25th 2023, and last updated in August 22nd 2022. Despite being inactive, 1450 other studies are still searching for willing participants."

Answered by AI

How widely dispersed is this medical experiment being conducted?

"Currently, this trial is recruiting at four sites -- Aurora, Denver and Colorado Springs to name a few. It may be beneficial for prospective participants to select the local site that requires minimal travel expenditure."

Answered by AI
~133 spots leftby Oct 2035