Trial · NCT05515978
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 27
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Successful accrual of 100 patients to the pragmatic trial in the first four years | 4 years | Once there are 6 months of follow-up data on the first 100 patients, a formal analysis will be done to determine the completeness of data and the potential for a powered study. Outcome measure was amended January 2025. |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Body Mass Index | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: Body Mass Index (BMI) |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Weight | 2 years | Metabolic response. Key metabolic parameter assessed as part of routine care: Weight |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on HbA1C | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: HbA1C |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Blood Pressure | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: blood pressure |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on Glucose Levels | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: random glucose level. |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - BMI | 2 years | Metabolic response. Key metabolic parameter assessed as part of routine care: Body Mass Index (BMI) |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - Weight | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: Weight |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - HbA1C | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: HbA1C |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - blood pressure | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: blood pressure |
| Secondary | Effectiveness: 1a: To determine the effectiveness of metformin prescribed in a pragmatic trial on key physiologic parameters - blood glucose levels | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: random glucose level. |
| Secondary | Effectiveness: 1b: To determine the effectiveness of metformin prescribed in a pragmatic trial on the development of diabetes. | 2 years | 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 |
| Secondary | Determine the number of additional diabetes medications initiated | 2 years | Metabolic response. Key metabolic parameters assessed as part of routine care: Initiation of any additional diabetes medication |
| Secondary | Determine the number of new diagnoses of diabetes | 2 years | 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 |
| Secondary | Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse cardiac events (MACE). | 2 years | 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). |
| Secondary | Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on rate of major adverse limb events (MALE). | 2 years | 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). |
| Secondary | 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. | 2 years | 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. |
| Secondary | Effectiveness: Measure the effectiveness of metformin prescribed on a pragmatic trial on PSA response of prostate cancer. | 2 years | 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?" |
| Secondary | Effectiveness: Measure the effectiveness of metformin prescribed in a pragmatic trial on radiographic progression of prostate cancer. | 10 years | Following every scan, the study associated provider will be asked "Does the subject have evidence of radiographic progression in your opinion" |
| Secondary | Effectiveness: To determine the effectiveness of metformin prescribed on a pragmatic trial ion overall and prostate cancer specific survival. | 10 years | 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. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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