Understanding the Effect of Metformin on Corus CAD (or ASGES) (MET)

January 29, 2019 updated by: CardioDx

Understanding the Effect of Metformin on Corus CAD (MET Study)

The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD (henceforth "Corus") in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study goal was to understand the effect of Metformin on Age/Sex/Gene Expression Score (ASGES) or Corus CAD in pre-diabetic patients who are medication naive. This study provided data to determine if the Corus CAD (ASGES) signature was different in pre-diabetic patients when metformin was newly prescribed and taken. The primary aim of this study was to evaluate whether metformin used in pre-diabetic patients to prevent progression to type II diabetes had a significant effect on the gene expression levels measured in Corus. This was a prospective study. Subjects were enrolled from participating sites as applicable inclusion/exclusion criteria were met. The study aimed to enroll approximately fifty (50) patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be enrolled from participating sites as applicable inclusion/exclusion criteria are met. The study aims to enroll approximately fifty (50) patients.

Description

Inclusion Criteria:

At least 21 years of age

Any of the following:

  • Chest pain syndrome, stable angina, or anginal equivalent suggesting myocardial ischemia
  • Low-risk unstable angina, or
  • Asymptomatic individuals with a high probability of CAD

Clinician diagnosis of pre-diabetes, per ADA guidelines, such that metformin therapy is prescribed:

  • HgA1C: >5.7% - <6.4%,
  • BMI> 35 kg/m2
  • Age< 60 yrs
  • Prior Gestational Diabetes Mellitus
  • FPG: >100mg/dl - <126mg/dl
  • OGTT: >140mg/dl - <200mg/dl Willingness to comply with metformin therapy, for at least seven (7) days (P.O., per physician's dosage discretion) Willingness to maintain a drug diary for duration of study, for full follow-up period (7 + 7 days) Willingness and ability to provide two (2) samples for Corus (baseline, 7 (+ 7) days post- medication start) Provide written informed consent

Exclusion Criteria:

  • History of or current level of HbA1C >6.5
  • History of or current prescription of metformin or any other diabetic medication
  • History of myocardial infarction (MI) or prior revascularization
  • Current MI or acute coronary syndrome (ACS)
  • Current New York Heart Association (NYHA) class III or IV congestive heart failure symptoms
  • Current systemic infectious or systemic inflammatory conditions
  • Subjects currently taking steroids, immunosuppressive agents or chemotherapeutic agents

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Corus CAD (ASGES) Post-metformin
Corus CAD (ASGES) second sample draw results to compare to Corus CAD (ASGES) first draw results (per patient).
Diagnostic test: Corus CAD (ASGES)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Metformin effect on Corus CAD
Time Frame: 7 days (+7days)
Observe the effect of metformin use on Corus CAD (age, sex, gene expression score - ASGES) results
7 days (+7days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CardioDx

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Mouton, MD, The Mouton Clinic

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 Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CDX_000018
  • MET Study (Other Identifier: CardioDx)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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