Back to resultsPragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Primary Purpose
Prostate Cancer
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Metformin
Lifestyle Modification
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- 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/m2
- Have a prostate cancer diagnosis
- Have a clinical relationship and planned visit with a participating provider at a UCHealth facility.
Exclusion Criteria:
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
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).
- 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)
- 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 operation and then implement a Spanish consent, as feasible.
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
- Any treating investigator concern, related to tolerance, safety, adherence or for any other reason
Sites / Locations
- Colorado Research CenterRecruiting
- UCHealth-Southern ColoradoRecruiting
- UCHealth-Metro DenverRecruiting
- UCHealth-Northern ColoradoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Metformin and Lifestyle Modification Arm
Lifestyle Modification Only Arm
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Successful accrual of 200 patients to the pragmatic trial in the first two years
Once there are 6 months of follow-up data on the first 200 patients, a formal analysis will be done to determine the completeness of data and the potential for a powered study.
Secondary Outcome Measures
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Body Mass Index
Metabolic response. Key metabolic parameters assessed as part of routine care:
Body Mass Index (BMI)
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Weight
Metabolic response. Key metabolic parameter assessed as part of routine care:
Weight
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on HbA1C
Metabolic response. Key metabolic parameters assessed as part of routine care:
HbA1C
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Blood Pressure
Metabolic response. Key metabolic parameters assessed as part of routine care:
blood pressure
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Glucose Levels
Metabolic response. Key metabolic parameters assessed as part of routine care:
random glucose level.
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - BMI
Metabolic response. Key metabolic parameter assessed as part of routine care:
Body Mass Index (BMI)
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - Weight
Metabolic response. Key metabolic parameters assessed as part of routine care:
Weight
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - HbA1C
Metabolic response. Key metabolic parameters assessed as part of routine care:
HbA1C
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - blood pressure
Metabolic response. Key metabolic parameters assessed as part of routine care:
blood pressure
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - blood glucose levels
Metabolic response. Key metabolic parameters assessed as part of routine care:
random glucose level.
Effectiveness: 1b: To determine the effectiveness of metformin prescribed in a pragmatic trial on the development of diabetes.
Metabolic response. Key metabolic parameters assessed as part of routine care:
1b: Initiation of any additional diabetes medication, and new diagnoses of diabetes. All new diagnoses of diabetes will be reviewed by the adjudication committee
Determine the number of additional diabetes medications initiated
Metabolic response. Key metabolic parameters assessed as part of routine care:
Initiation of any additional diabetes medication
Determine the number of new diagnoses of diabetes
Metabolic response. Key metabolic parameters assessed as part of routine care:
New diagnoses of diabetes. All new diagnoses of diabetes will be reviewed by the adjudication committee
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse cardiac events (MACE).
All major adverse cardiac events will undergo chart review and categorized as major cardiac and limb events (MI, stroke, CV death, acute limb ischemia, major vascular amputation).
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse limb events (MALE).
All major adverse cardiac events will undergo chart review and categorized as major cardiac and limb events (MI, stroke, CV death, acute limb ischemia, major vascular amputation).
Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial in progression-free survival defined as doubling of PSA level or all-cause mortality.
PSA doubling as surrogate for progression, defined using a modified approach from the prostate cancer working group 3(PCWG 2016)1.. First all PSA values less than 1 ng/dL will be set to 1 ng/dL. If this PSA value is 1 ng/dL an event (i.e., PSA doubling or death) will be defined as the next PSA value that was greater than or equal to 2 ng/dL or death. Alternatively, if a patient's first PSA is greater than 1 ng/dL the nadir was identified. If the variability in PSA values prior to the nadir is low (i.e., there was less than a 5% difference between the nadir and previous PSA values) the first value prior to the nadir that is within 5% will be selected as the baseline PSA. An event will be defined as the next PSA value that was greater or equal to 2 times the baseline PSA or death. Patients that never experienced a PSA doubling or death will be censored at their last known PSA measurement.
Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial on PSA response of prostate cancer.
A modified PSA biochemical response: PSA response defined as a ≥50% decline in PSA from the baseline level at the start of the study. The study-associated provider will receive a clinical decision support query with any PSA response observed: "Is it likely that any other intervention such as additional medical or local therapy besides metformin may have caused the subjects recent PSA response?"
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on radiographic progression of prostate cancer.
Following every scan, the study associated provider will be asked "Does the subject have evidence of radiographic progression in your opinion"
Effectiveness: To determine the effectiveness of metformin prescribed on a pragmatic trial ion overall and prostate cancer specific survival.
Overall and prostate cancer specific mortality: The Colorado State Death Registry, which is integrated with Health Data Compass (HDC), will be used to determine the overall survival status. The subject's trial-associated provider will receive a clinical decision support query from the study regarding any subject who dies on the trial: "Did this subject die due to complications of prostate cancer?" (Investigator assessment). Every death will be chart reviewed.
Safety: To determine the safety, assessed by Adverse Events, of providing metformin via this pragmatic approach.
Safety endpoints via HDC (death, hospitalization, and metformin-associated lactate level elevation diagnosis codes frequency). Lab values, such as a lactate level, may also be utilized for specific diagnosis. The PI and steering committee will review these on a regular basis any notify the IRB with a notable difference between the arms. Metformin-associated lactic acidosis will specifically be an AE of interest.
Reach: To determine the proportion of patients approached who enroll and the characteristics and representativeness of those enrolled.
The number, proportion, and demographics of eligible patients: eligible patients include those deemed eligible to receive a consent in MHC/Epic through assessment of the demographic information. The proportion will be determined by dividing the number of patients who sign the second consent by those who received the first consent. The demographics of those who signed the second consent will be compared with those who signed the initial consent.
Implementation: To determine the accuracy of the Epic screening process to identify
Accuracy of Epic screening process: The charts of the first 50 patients identified by Epic will be reviewed manually by the PI and study team.
Implementation: To determine the effectiveness of different approaches to presenting the consent to patients in MHC/Epic.
The consent completion rate as determined by the electronic signature of the consent in MHC/Epic within one month of availability or posting and also at any timepoint thereafter (early versus late completion).
Implementation: To determine the time period required to identify and enroll 200 eligible patients
Study Enrollment: The number of patients who sign the second consent (consent #2 or #3) in MHC/Epic will be counted toward study accrual and the time it takes to enroll 200 will be assessed.
Implementation: To determine the accuracy of TriNetX in predicting the number of eligible patients identified each month.
Accuracy of TriNetX estimates of eligible patients, including filtering for appointments with participating providers, will be compared with the number of consents released in MHC/Epic monthly.
Adherence: To determine the number and proportion of patients who adhere to the assigned treatment plan.
The proportion of patients with active metformin prescription at one year after enrollment and then annually will be assessed. The number of patients in the non-metformin arm who start metformin and/or another anti-diabetes medication during the study period will be assessed.
Full Information
NCT ID
NCT05515978
First Posted
May 17, 2021
Last Updated
April 4, 2023
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT05515978
Brief Title
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
Official Title
A Randomized, Pragmatic, Adaptive Trial of Metformin for Glucose Intolerance or Increased Body Mass Index in Prostate Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 17, 2022 (Actual)
Primary Completion Date
October 20, 2035 (Anticipated)
Study Completion Date
November 6, 2036 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
Detailed Description
In this study, subjects with prostate cancer will be randomized to metformin plus educational material for lifestyle modification versus educational material for lifestyle modification alone and followed for up to 10 years. Population-based, retrospective studies have reported improved outcomes, including prostate cancer specific mortality, with the incidental use of metformin in prostate cancer patients. One prominent study is this area from Margel, et al was published in 2013.2 Using the administrative database from several Ontario health districts, men aged 66 with incidental diabetes and prostate cancer antigen (PCA) were studied. The study included over 3000 men and found an adjusted hazard ratio of 0.76 (95% CI, 0.64 to 0.89) for PCA-specific mortality for each additional 6 months of metformin use. There was no relationship to survival with any other diabetic medication.
In addition to the use of metformin for the prevention of metabolic complications related to obesity and the prevention of diabetes, there are several studies reporting a potential benefit in those with prostate cancer. In a Veterans Administration-based study, more than 87,000 subjects were identified with PCA in the sample.3 The subjects were analyzed in 3 cohorts: 1) no diabetic medication (DM), 2) DM without metformin use and 3) DM with metformin use. Men with DM who were treated with metformin were found to have improved OS (HR 0.82, 95% CI 0.78 - 0.86, for mortality) compared to men with DM not on metformin. Reduced cancer specific mortality was also observed in the men with DM on metformin (HR 0.70, 95% CI 0.64 -0.77) in comparison to men with DM not taking metformin (HR 0.93, 95% CI 0.85 -1.00) - the reference group were those without DM. Despite considerable interest in these findings, there is little if any prospective data on the use of metformin in this setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
In this pragmatic trial, a 2-step electronic consent approach to enroll patients in the metformin + lifestyle modification or lifestyle modification arms will be used. The initial consent will invite patients to join a cohort to study prostate cancer and it will describe the general pragmatic framework under which this protocol will take place with the opportunity for additional trial opportunities. Subsequent consents will be limited to those who consented to the initial project and are found to be eligible for a specific trial (e.g. this metformin/lifestyle intervention trial). Within the framework of this pragmatic trial and electronic self-consent, these subsequent consents will be more focused and limited to the specific involvement in the arm in which they have been randomized. This general approach will follow the trials within cohorts paradigm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Metformin and Lifestyle Modification Arm
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lifestyle Modification Only Arm
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modification
Intervention Description
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 Information:
Title
Successful accrual of 200 patients to the pragmatic trial in the first two years
Description
Once there are 6 months of follow-up data on the first 200 patients, a formal analysis will be done to determine the completeness of data and the potential for a powered study.
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Body Mass Index
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
Body Mass Index (BMI)
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Weight
Description
Metabolic response. Key metabolic parameter assessed as part of routine care:
Weight
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on HbA1C
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
HbA1C
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Blood Pressure
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
blood pressure
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Glucose Levels
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
random glucose level.
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - BMI
Description
Metabolic response. Key metabolic parameter assessed as part of routine care:
Body Mass Index (BMI)
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - Weight
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
Weight
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - HbA1C
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
HbA1C
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - blood pressure
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
blood pressure
Time Frame
2 years
Title
Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - blood glucose levels
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
random glucose level.
Time Frame
2 years
Title
Effectiveness: 1b: To determine the effectiveness of metformin prescribed in a pragmatic trial on the development of diabetes.
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
1b: Initiation of any additional diabetes medication, and new diagnoses of diabetes. All new diagnoses of diabetes will be reviewed by the adjudication committee
Time Frame
2 years
Title
Determine the number of additional diabetes medications initiated
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
Initiation of any additional diabetes medication
Time Frame
2 years
Title
Determine the number of new diagnoses of diabetes
Description
Metabolic response. Key metabolic parameters assessed as part of routine care:
New diagnoses of diabetes. All new diagnoses of diabetes will be reviewed by the adjudication committee
Time Frame
2 years
Title
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse cardiac events (MACE).
Description
All major adverse cardiac events will undergo chart review and categorized as major cardiac and limb events (MI, stroke, CV death, acute limb ischemia, major vascular amputation).
Time Frame
2 years
Title
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse limb events (MALE).
Description
All major adverse cardiac events will undergo chart review and categorized as major cardiac and limb events (MI, stroke, CV death, acute limb ischemia, major vascular amputation).
Time Frame
2 years
Title
Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial in progression-free survival defined as doubling of PSA level or all-cause mortality.
Description
PSA doubling as surrogate for progression, defined using a modified approach from the prostate cancer working group 3(PCWG 2016)1.. First all PSA values less than 1 ng/dL will be set to 1 ng/dL. If this PSA value is 1 ng/dL an event (i.e., PSA doubling or death) will be defined as the next PSA value that was greater than or equal to 2 ng/dL or death. Alternatively, if a patient's first PSA is greater than 1 ng/dL the nadir was identified. If the variability in PSA values prior to the nadir is low (i.e., there was less than a 5% difference between the nadir and previous PSA values) the first value prior to the nadir that is within 5% will be selected as the baseline PSA. An event will be defined as the next PSA value that was greater or equal to 2 times the baseline PSA or death. Patients that never experienced a PSA doubling or death will be censored at their last known PSA measurement.
Time Frame
2 years
Title
Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial on PSA response of prostate cancer.
Description
A modified PSA biochemical response: PSA response defined as a ≥50% decline in PSA from the baseline level at the start of the study. The study-associated provider will receive a clinical decision support query with any PSA response observed: "Is it likely that any other intervention such as additional medical or local therapy besides metformin may have caused the subjects recent PSA response?"
Time Frame
2 years
Title
Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on radiographic progression of prostate cancer.
Description
Following every scan, the study associated provider will be asked "Does the subject have evidence of radiographic progression in your opinion"
Time Frame
10 years
Title
Effectiveness: To determine the effectiveness of metformin prescribed on a pragmatic trial ion overall and prostate cancer specific survival.
Description
Overall and prostate cancer specific mortality: The Colorado State Death Registry, which is integrated with Health Data Compass (HDC), will be used to determine the overall survival status. The subject's trial-associated provider will receive a clinical decision support query from the study regarding any subject who dies on the trial: "Did this subject die due to complications of prostate cancer?" (Investigator assessment). Every death will be chart reviewed.
Time Frame
10 years
Title
Safety: To determine the safety, assessed by Adverse Events, of providing metformin via this pragmatic approach.
Description
Safety endpoints via HDC (death, hospitalization, and metformin-associated lactate level elevation diagnosis codes frequency). Lab values, such as a lactate level, may also be utilized for specific diagnosis. The PI and steering committee will review these on a regular basis any notify the IRB with a notable difference between the arms. Metformin-associated lactic acidosis will specifically be an AE of interest.
Time Frame
2 years
Title
Reach: To determine the proportion of patients approached who enroll and the characteristics and representativeness of those enrolled.
Description
The number, proportion, and demographics of eligible patients: eligible patients include those deemed eligible to receive a consent in MHC/Epic through assessment of the demographic information. The proportion will be determined by dividing the number of patients who sign the second consent by those who received the first consent. The demographics of those who signed the second consent will be compared with those who signed the initial consent.
Time Frame
2 years
Title
Implementation: To determine the accuracy of the Epic screening process to identify
Description
Accuracy of Epic screening process: The charts of the first 50 patients identified by Epic will be reviewed manually by the PI and study team.
Time Frame
2 years
Title
Implementation: To determine the effectiveness of different approaches to presenting the consent to patients in MHC/Epic.
Description
The consent completion rate as determined by the electronic signature of the consent in MHC/Epic within one month of availability or posting and also at any timepoint thereafter (early versus late completion).
Time Frame
2 years
Title
Implementation: To determine the time period required to identify and enroll 200 eligible patients
Description
Study Enrollment: The number of patients who sign the second consent (consent #2 or #3) in MHC/Epic will be counted toward study accrual and the time it takes to enroll 200 will be assessed.
Time Frame
2 years
Title
Implementation: To determine the accuracy of TriNetX in predicting the number of eligible patients identified each month.
Description
Accuracy of TriNetX estimates of eligible patients, including filtering for appointments with participating providers, will be compared with the number of consents released in MHC/Epic monthly.
Time Frame
2 years
Title
Adherence: To determine the number and proportion of patients who adhere to the assigned treatment plan.
Description
The proportion of patients with active metformin prescription at one year after enrollment and then annually will be assessed. The number of patients in the non-metformin arm who start metformin and/or another anti-diabetes medication during the study period will be assessed.
Time Frame
10 years
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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/m2
Have a prostate cancer diagnosis
Have a clinical relationship and planned visit with a participating provider at a UCHealth facility.
Exclusion Criteria:
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
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).
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)
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 operation and then implement a Spanish consent, as feasible.
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
Any treating investigator concern, related to tolerance, safety, adherence or for any other reason
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaquelyn Schrack
Phone
72084808879
Email
jaquelyn.schrack@cuanschutz.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Robyn Swing
Phone
7208480607
Email
robyn.swing@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Flaig, MD
Organizational Affiliation
Colorado Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Colorado Research Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Martin
Phone
720-848-0657
Email
anne.c.martin@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Robyn Swing
Phone
7208480607
Email
robyn.swing@cuanschutz.edu
First Name & Middle Initial & Last Name & Degree
Thomas Flaig, MD
Facility Name
UCHealth-Southern Colorado
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80863
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Graf
Email
elizabeth.graf@uchealth.org
First Name & Middle Initial & Last Name & Degree
Robert Hoyer
Facility Name
UCHealth-Metro Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robyn Swing
Phone
720-848-0650
Email
robyn.swing@cuanschutz.edu
Facility Name
UCHealth-Northern Colorado
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80521
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Twombly
Phone
970-491-1553
Email
sara.twombly@uchealth.org
First Name & Middle Initial & Last Name & Degree
Steven Schuster
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pragmatic Trial of Metformin for Glucose Intolerance or Increased BMI in Prostate Cancer Patients
We'll reach out to this number within 24 hrs